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出境医 / 临床实验 / Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer

Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer

Study Description
Brief Summary:
Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer

Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Procedure: Resection Radiation: Radiotherapy Drug: Chemotherapy Procedure: Salvage neck dissection Phase 4

Detailed Description:
This trial investigates the effectiveness of transoral head and neck surgery (TOS) for locally advanced, but transorally resectable oropharyngeal cancer followed by risk-adapted adjuvant therapy versus primary radiochemotherapy (definitive chemoradiotherapy, CRTX). Both treatments are internationally accepted standards. The choice of the treatment strategy depends on the preference of the responsible attending physician and on the country of residence. Internationally, mostly definitive chemoradiotherapy is regarded as the standard of care for oropharyngeal cancer. In Germany, however, transoral surgical resection is also well established and commonly practiced. The key question therefore is whether one of the two therapies is more effective than the other in clinical daily routine under the given conditions of our health care system and with a realistic, non-ideal patient cohort. For this reason, a comparative effectiveness research (CER) concept will be applied in this setting. The aim of this trial is primarily to show a superiority of the surgical approach in terms of local and locoregional control and secondarily to compare functional outcome and quality of life.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective, two-arm, open label, multicenter, randomized, controlled comparative effectiveness study.

The trial is based on an event-driven design: the final analysis will be performed when all events have been observed or the study was terminated at one of the interim analyses.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : June 5, 2023
Estimated Study Completion Date : June 5, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Resection/adjuvant radio(-chemo)therapy
  • Transoral surgical resection within 4 weeks after randomization
  • Neck dissection can be performed during resection of the primary tumor or within 4 weeks after randomization
  • 6-7 weeks standard risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy according to arm B if necessary), start within 6 weeks post-surgery
 Procedure: Resection
Definitive surgery should generally be performed within 2 weeks, but not more than 4 weeks after randomization. The appropriately indicated neck dissection(s) may be performed either prior to, during the same session, or within 2 weeks after the resection of the primary tumor, but not later than 4 weeks following randomization. The primary tumor is to be resected with clear margins (R0) and en bloc in all cases. Frozen section assessment must be routinely and readily available.
Other Name: Transoral Surgery

Radiation: Radiotherapy
6-7 weeks standard risk-adapted adjuvant radiotherapy 56-66 Gy, start within 6 weeks post-surgery Arm B: 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization, 70-72 Gy, SIB possible

Drug: Chemotherapy
The investigational medicinal product (IMP) are the chemotherapeutical drugs Cisplatin, Mitomycin C and 5-FU. According to local routine, chemotherapy protocols as listed in study protocol should be used.
Active Comparator: Adjuvant radio(-chemo)therapy/salvage neck dissection
  • 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization
  • 70-72 Gy, SIB possible
  • Cisplatin 100 mg/m2 on days 1, 22, 43 or Cisplatin once weekly (30-40 mg/m2) on days 1, 8, 15, 22, 29, 36 or Mitomycin C 10 mg/m2 d1, 29 and 5-FU 600 mg/m2/day iv on days 1-5 or Cisplatin 20 mg/m² + 5-FU 600 mg/m²/day iv d 1-5 and 29-33
  • +/- Salvage neck dissection 12±2 weeks after treatment
 Radiation: Radiotherapy
6-7 weeks standard risk-adapted adjuvant radiotherapy 56-66 Gy, start within 6 weeks post-surgery Arm B: 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization, 70-72 Gy, SIB possible

Drug: Chemotherapy
The investigational medicinal product (IMP) are the chemotherapeutical drugs Cisplatin, Mitomycin C and 5-FU. According to local routine, chemotherapy protocols as listed in study protocol should be used.

Procedure: Salvage neck dissection
+/- Salvage neck dissection 12±2 weeks after treatment
Outcome Measures
Primary Outcome Measures :
  1. Time to local or locoregional failure or death from any cause [ Time Frame: Defined as time from randomization up to 36 month ]
    The primary objective of this study is to evaluate the effectiveness of primary surgical versus non-surgical treatment of patients with locally advanced, but transorally resectable oropharyngeal cancer in terms of time to local or locoregional failure or death from any cause (LRF).


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Until 3 years after randomization ]
    Overall survival (OS) in both study arms, follow-up visits until the end of study

  2. Disease-free survival [ Time Frame: Until 3 years after randomization ]
    Disease-free survival (DFS) in both study arms. CT- Scans will be performed at month 3, month 6, 18, 30 and in case of suspicion of recurrence

  3. Effectiveness in terms of toxicity [ Time Frame: Until 3 years after randomization ]
    Effectiveness in terms of toxicity in both study arms. Monitoring of AE's/SAE's from randomization to 28 days after the last administration of IMP and/or 5 months after randomization in this trial

  4. Effectiveness in terms of morbidity [ Time Frame: Until 3 years after randomization ]
    Effectiveness in terms of morbidity (including swallowing function by MDADI Score) by late morbidity documentation in both study arms.

  5. Quality of life evaluated by patient [ Time Frame: Until 3 years after randomization ]
    Quality of life Questionnaires using QLQ H&N-43 in both study arms

  6. Quality of life evaluated by patient [ Time Frame: Until 3 years after randomization ]
    CareQuality of life Questionnaires using EORTC QLQ-C30 both study arms

  7. Cost-utility [ Time Frame: Until 3 years after randomization ]
    Cost-utility in both study armsusing Questionnaire Health Care Utilization and Productivity loss.

  8. Cost-effectiveness [ Time Frame: Until 3 years after randomization ]
    Cost-effectiveness in both study arms using Questionnaire Health Utilization and Productivity loss.


Other Outcome Measures:
  1. Tertiary objectives include comparisons of treatment effects between HPV- Status [ Time Frame: Up to 36 month ]
    Subgroup analysis of HPV-positive and HPV-negative oropharynx carcinoma


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven SCC of the oropharynx; T1, N2a-c, M0; T2, N1-2c, M0; T3, N0-2c, M0, with only amendable to transoral resection)
  • Primary tumor must be resectable through transoral approach
  • p16 immunohistochemitry by local pathology or FFPE tissue must be available for central HPV diagnostic
  • Written and signed informed consent
  • Briefing through surgeon and radiation oncologist
  • ECOG PS ≥2, Karnofsky PS ≥ 60 %
  • Age ≥ 18
  • Curative treatment intent
  • Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 80 x 109/L, hemoglobin > 9.5 g/dL
  • Adequate liver function: Bilirubin < 2.0 g/dL, SGOT, SGPT, < 3 x ULN
  • If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
  • dental examination and appropriate dental therapy if needed prior to Confidential TopROC 2017_03_24 Version 1.0 Seite 15 von 124 beginning of radiotherapy
  • Nutritional evaluation prior to initiation of therapy and optional prophylactic gastrostomy (PEG) tube placement

Exclusion Criteria:

  • Prior invasive malignancy except controlled skin cancer or carcinoma in situ of cervix
  • Unknown primary (CUP), nasopharynx, hypopharynx, laryngeal or salivary gland cancer
  • Metastatic disease
  • Serious co-morbidity, e.g. high-grade carotid artery stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C
  • Hemoglobin level <9.5g/dl within 4 weeks before randomization
  • Pregnancy or lactation
  • Women of child-bearing potential with unclear contraception
  • Previous treatment with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
  • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
  • Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol
  • Patients institutionalized by official means or court order
  • Deficient
Contacts and Locations

Locations
Show Show 20 study locations
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Charite University, Berlin, Germany
University Medical Center Gießen and Marburg GmbH
University Hospital Ulm
Investigators
Layout table for investigator information
Principal Investigator: Chia-Jung Busch, PD Dr. Universitätsklinikum Hamburg-Eppendorf
Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date December 11, 2020
Actual Study Start Date  ICMJE January 5, 2018
Estimated Primary Completion Date June 5, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018) 		Time to local or locoregional failure or death from any cause [ Time Frame: Defined as time from randomization up to 36 month ]
The primary objective of this study is to evaluate the effectiveness of primary surgical versus non-surgical treatment of patients with locally advanced, but transorally resectable oropharyngeal cancer in terms of time to local or locoregional failure or death from any cause (LRF).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • Overall survival [ Time Frame: Until 3 years after randomization ]
    Overall survival (OS) in both study arms, follow-up visits until the end of study
  • Disease-free survival [ Time Frame: Until 3 years after randomization ]
    Disease-free survival (DFS) in both study arms. CT- Scans will be performed at month 3, month 6, 18, 30 and in case of suspicion of recurrence
  • Effectiveness in terms of toxicity [ Time Frame: Until 3 years after randomization ]
    Effectiveness in terms of toxicity in both study arms. Monitoring of AE's/SAE's from randomization to 28 days after the last administration of IMP and/or 5 months after randomization in this trial
  • Effectiveness in terms of morbidity [ Time Frame: Until 3 years after randomization ]
    Effectiveness in terms of morbidity (including swallowing function by MDADI Score) by late morbidity documentation in both study arms.
  • Quality of life evaluated by patient [ Time Frame: Until 3 years after randomization ]
    Quality of life Questionnaires using QLQ H&N-43 in both study arms
  • Quality of life evaluated by patient [ Time Frame: Until 3 years after randomization ]
    CareQuality of life Questionnaires using EORTC QLQ-C30 both study arms
  • Cost-utility [ Time Frame: Until 3 years after randomization ]
    Cost-utility in both study armsusing Questionnaire Health Care Utilization and Productivity loss.
  • Cost-effectiveness [ Time Frame: Until 3 years after randomization ]
    Cost-effectiveness in both study arms using Questionnaire Health Utilization and Productivity loss.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 28, 2018) 		Tertiary objectives include comparisons of treatment effects between HPV- Status [ Time Frame: Up to 36 month ]
Subgroup analysis of HPV-positive and HPV-negative oropharynx carcinoma
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
Official Title  ICMJE Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
Brief Summary Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer
Detailed Description This trial investigates the effectiveness of transoral head and neck surgery (TOS) for locally advanced, but transorally resectable oropharyngeal cancer followed by risk-adapted adjuvant therapy versus primary radiochemotherapy (definitive chemoradiotherapy, CRTX). Both treatments are internationally accepted standards. The choice of the treatment strategy depends on the preference of the responsible attending physician and on the country of residence. Internationally, mostly definitive chemoradiotherapy is regarded as the standard of care for oropharyngeal cancer. In Germany, however, transoral surgical resection is also well established and commonly practiced. The key question therefore is whether one of the two therapies is more effective than the other in clinical daily routine under the given conditions of our health care system and with a realistic, non-ideal patient cohort. For this reason, a comparative effectiveness research (CER) concept will be applied in this setting. The aim of this trial is primarily to show a superiority of the surgical approach in terms of local and locoregional control and secondarily to compare functional outcome and quality of life.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective, two-arm, open label, multicenter, randomized, controlled comparative effectiveness study.

The trial is based on an event-driven design: the final analysis will be performed when all events have been observed or the study was terminated at one of the interim analyses.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oropharyngeal Cancer
Intervention  ICMJE
  • Procedure: Resection
    Definitive surgery should generally be performed within 2 weeks, but not more than 4 weeks after randomization. The appropriately indicated neck dissection(s) may be performed either prior to, during the same session, or within 2 weeks after the resection of the primary tumor, but not later than 4 weeks following randomization. The primary tumor is to be resected with clear margins (R0) and en bloc in all cases. Frozen section assessment must be routinely and readily available.
    Other Name: Transoral Surgery
  • Radiation: Radiotherapy
    6-7 weeks standard risk-adapted adjuvant radiotherapy 56-66 Gy, start within 6 weeks post-surgery Arm B: 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization, 70-72 Gy, SIB possible
  • Drug: Chemotherapy
    The investigational medicinal product (IMP) are the chemotherapeutical drugs Cisplatin, Mitomycin C and 5-FU. According to local routine, chemotherapy protocols as listed in study protocol should be used.
  • Procedure: Salvage neck dissection
    +/- Salvage neck dissection 12±2 weeks after treatment
Study Arms  ICMJE
  • Experimental: Resection/adjuvant radio(-chemo)therapy
    • Transoral surgical resection within 4 weeks after randomization
    • Neck dissection can be performed during resection of the primary tumor or within 4 weeks after randomization
    • 6-7 weeks standard risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy according to arm B if necessary), start within 6 weeks post-surgery
    Interventions:
    • Procedure: Resection
    • Radiation: Radiotherapy
    • Drug: Chemotherapy
  • Active Comparator: Adjuvant radio(-chemo)therapy/salvage neck dissection
    • 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization
    • 70-72 Gy, SIB possible
    • Cisplatin 100 mg/m2 on days 1, 22, 43 or Cisplatin once weekly (30-40 mg/m2) on days 1, 8, 15, 22, 29, 36 or Mitomycin C 10 mg/m2 d1, 29 and 5-FU 600 mg/m2/day iv on days 1-5 or Cisplatin 20 mg/m² + 5-FU 600 mg/m²/day iv d 1-5 and 29-33
    • +/- Salvage neck dissection 12±2 weeks after treatment
    Interventions:
    • Radiation: Radiotherapy
    • Drug: Chemotherapy
    • Procedure: Salvage neck dissection
Publications *
  • Mehanna H, Beech T, Nicholson T, El-Hariry I, McConkey C, Paleri V, Roberts S. Prevalence of human papillomavirus in oropharyngeal and nonoropharyngeal head and neck cancer--systematic review and meta-analysis of trends by time and region. Head Neck. 2013 May;35(5):747-55. doi: 10.1002/hed.22015. Epub 2012 Jan 20. Review.
  • Licitra L, Zigon G, Gatta G, Sánchez MJ, Berrino F; EUROCARE Working Group. Human papillomavirus in HNSCC: a European epidemiologic perspective. Hematol Oncol Clin North Am. 2008 Dec;22(6):1143-53, vii-viii. doi: 10.1016/j.hoc.2008.10.002. Review.
  • Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.
  • Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tân PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
  • Weinberger PM, Yu Z, Haffty BG, Kowalski D, Harigopal M, Brandsma J, Sasaki C, Joe J, Camp RL, Rimm DL, Psyrri A. Molecular classification identifies a subset of human papillomavirus--associated oropharyngeal cancers with favorable prognosis. J Clin Oncol. 2006 Feb 10;24(5):736-47. Epub 2006 Jan 9.
  • Pfister DG, Spencer S, Brizel DM, Burtness B, Busse PM, Caudell JJ, Cmelak AJ, Colevas AD, Dunphy F, Eisele DW, Gilbert J, Gillison ML, Haddad RI, Haughey BH, Hicks WL Jr, Hitchcock YJ, Jimeno A, Kies MS, Lydiatt WM, Maghami E, Martins R, McCaffrey T, Mell LK, Mittal BB, Pinto HA, Ridge JA, Rodriguez CP, Samant S, Schuller DE, Shah JP, Weber RS, Wolf GT, Worden F, Yom SS, McMillian NR, Hughes M; National Comprehensive Cancer Network. Head and neck cancers, Version 2.2014. Clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2014 Oct;12(10):1454-87.
  • Grégoire V, Lefebvre JL, Licitra L, Felip E; EHNS-ESMO-ESTRO Guidelines Working Group. Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v184-6. doi: 10.1093/annonc/mdq185.
  • Wegscheider K, Drabik A, Bleich C, Schulz H. [Benefit assessment in health services research and epidemiology]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2015 Mar;58(3):298-307. doi: 10.1007/s00103-014-2106-1. German.
  • Lörincz BB, Möckelmann N, Busch CJ, Knecht R. Functional outcomes, feasibility, and safety of resection of transoral robotic surgery: single-institution series of 35 consecutive cases of transoral robotic surgery for oropharyngeal squamous cell carcinoma. Head Neck. 2015 Nov;37(11):1618-24. doi: 10.1002/hed.23809. Epub 2014 Aug 28.
  • Boscolo-Rizzo P, Gava A, Baggio V, Marchiori C, Stellin M, Fuson R, Lamon S, Da Mosto MC. Matched survival analysis in patients with locoregionally advanced resectable oropharyngeal carcinoma: platinum-based induction and concurrent chemoradiotherapy versus primary surgical resection. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):154-60. doi: 10.1016/j.ijrobp.2010.01.032. Epub 2010 Sep 23.
  • Hicks WL Jr, Kuriakose MA, Loree TR, Orner JB, Schwartz G, Mullins A, Donaldson C, Winston JM, Bakamjian VY. Surgery versus radiation therapy as single-modality treatment of tonsillar fossa carcinoma: the Roswell Park Cancer Institute experience (1971-1991). Laryngoscope. 1998 Jul;108(7):1014-9.
  • O'Hara J, MacKenzie K. Surgical versus non-surgical management of early stage oropharyngeal squamous cell carcinoma. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):437-42. doi: 10.1007/s00405-010-1362-4. Epub 2010 Aug 27.
  • Bußmann L, Laban S, Wittekindt C, Stromberger C, Tribius S, Möckelmann N, Böttcher A, Betz CS, Klussmann JP, Budach V, Muenscher A, Busch CJ. Comparative effectiveness trial of transoral head and neck surgery followed by adjuvant radio(chemo)therapy versus primary radiochemotherapy for oropharyngeal cancer (TopROC). BMC Cancer. 2020 Jul 29;20(1):701. doi: 10.1186/s12885-020-07127-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018) 		280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 5, 2023
Estimated Primary Completion Date June 5, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven SCC of the oropharynx; T1, N2a-c, M0; T2, N1-2c, M0; T3, N0-2c, M0, with only amendable to transoral resection)
  • Primary tumor must be resectable through transoral approach
  • p16 immunohistochemitry by local pathology or FFPE tissue must be available for central HPV diagnostic
  • Written and signed informed consent
  • Briefing through surgeon and radiation oncologist
  • ECOG PS ≥2, Karnofsky PS ≥ 60 %
  • Age ≥ 18
  • Curative treatment intent
  • Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 80 x 109/L, hemoglobin > 9.5 g/dL
  • Adequate liver function: Bilirubin < 2.0 g/dL, SGOT, SGPT, < 3 x ULN
  • If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
  • dental examination and appropriate dental therapy if needed prior to Confidential TopROC 2017_03_24 Version 1.0 Seite 15 von 124 beginning of radiotherapy
  • Nutritional evaluation prior to initiation of therapy and optional prophylactic gastrostomy (PEG) tube placement

Exclusion Criteria:

  • Prior invasive malignancy except controlled skin cancer or carcinoma in situ of cervix
  • Unknown primary (CUP), nasopharynx, hypopharynx, laryngeal or salivary gland cancer
  • Metastatic disease
  • Serious co-morbidity, e.g. high-grade carotid artery stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C
  • Hemoglobin level <9.5g/dl within 4 weeks before randomization
  • Pregnancy or lactation
  • Women of child-bearing potential with unclear contraception
  • Previous treatment with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
  • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
  • Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol
  • Patients institutionalized by official means or court order
  • Deficient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03691441
Other Study ID Numbers  ICMJE TopROC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE
  • Charite University, Berlin, Germany
  • University Medical Center Gießen and Marburg GmbH
  • University Hospital Ulm
Investigators  ICMJE
Principal Investigator: Chia-Jung Busch, PD Dr. Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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