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出境医 / 临床实验 / Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

Study Description
Brief Summary:
The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.

Condition or disease Intervention/treatment Phase
Cisplatin Carboplatin NPC Drug: Docetaxel,Carboplatin Drug: Docetaxel,Cisplatin Radiation: Carboplatin-based concurrent chemoradiotherapy Radiation: Cisplatin-based concurrent chemoradiotherapy Phase 3

Detailed Description:
Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Carboplatin
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy.
 Drug: Docetaxel,Carboplatin
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
Other Name: TC induction chemotherapy

Radiation: Carboplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent carboplatin
Active Comparator: Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy.
 Drug: Docetaxel,Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
Other Name: TP induction chemotherapy

Radiation: Cisplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin
Outcome Measures
Primary Outcome Measures :
  1. Failure-free survival [ Time Frame: 3-year ]
    Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.


Secondary Outcome Measures :
  1. Locoregional failure-free survival [ Time Frame: 3-year ]
    Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.

  2. Distant failure-free survival [ Time Frame: 3-year ]
    Distant failure-free survival is calculated from randomisation to the first locoregional failure.

  3. The initial response rates after treatments [ Time Frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy. ]
    The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.

  4. Toxic effects [ Time Frame: 3-year ]
    Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.

  5. Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  • Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition).
  • No evidence of distant metastasis (M0).
  • Satisfactory performance status: Karnofsky scale (KPS) > 70.
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: creatinine clearance ≥60 ml/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age ≥65 years or <18 years.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jian Guan, Ph.D. +86-13632102247 51643930@qq.com

Locations
Layout table for location information
China, Guangdong
Southern medical university Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jian Guan, M.D.    86+13632102247    guanjian5461@163.com   
Principal Investigator: Jian Guan, M.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Layout table for investigator information
Study Chair: Jian Guan Nanfang Hospital of Southern Medical University
Tracking Information
First Submitted Date  ICMJE April 25, 2018
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE January 31, 2018
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2019) 		Failure-free survival [ Time Frame: 3-year ]
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2019)
  • Locoregional failure-free survival [ Time Frame: 3-year ]
    Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.
  • Distant failure-free survival [ Time Frame: 3-year ]
    Distant failure-free survival is calculated from randomisation to the first locoregional failure.
  • The initial response rates after treatments [ Time Frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy. ]
    The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.
  • Toxic effects [ Time Frame: 3-year ]
    Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.
  • Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title  ICMJE Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Brief Summary The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.
Detailed Description Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cisplatin
  • Carboplatin
  • NPC
Intervention  ICMJE
  • Drug: Docetaxel,Carboplatin
    Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
    Other Name: TC induction chemotherapy
  • Drug: Docetaxel,Cisplatin
    Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
    Other Name: TP induction chemotherapy
  • Radiation: Carboplatin-based concurrent chemoradiotherapy
    Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
    Other Name: Radical radiotherapy and concurrent carboplatin
  • Radiation: Cisplatin-based concurrent chemoradiotherapy
    Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
    Other Name: Radical radiotherapy and concurrent cisplatin
Study Arms  ICMJE
  • Experimental: Carboplatin
    Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy.
    Interventions:
    • Drug: Docetaxel,Carboplatin
    • Radiation: Carboplatin-based concurrent chemoradiotherapy
  • Active Comparator: Cisplatin
    Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy.
    Interventions:
    • Drug: Docetaxel,Cisplatin
    • Radiation: Cisplatin-based concurrent chemoradiotherapy
Publications *
  • Haddad RI, Shin DM. Recent advances in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1143-54. doi: 10.1056/NEJMra0707975.
  • Guan J, Zhang Y, Li Q, Zhang Y, Li L, Chen M, Xiao N, Chen L. A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC). Oncotarget. 2016 Oct 25;7(43):70185-70193. doi: 10.18632/oncotarget.11824.
  • Hashibe M, Brennan P, Chuang SC, Boccia S, Castellsague X, Chen C, Curado MP, Dal Maso L, Daudt AW, Fabianova E, Fernandez L, Wünsch-Filho V, Franceschi S, Hayes RB, Herrero R, Kelsey K, Koifman S, La Vecchia C, Lazarus P, Levi F, Lence JJ, Mates D, Matos E, Menezes A, McClean MD, Muscat J, Eluf-Neto J, Olshan AF, Purdue M, Rudnai P, Schwartz SM, Smith E, Sturgis EM, Szeszenia-Dabrowska N, Talamini R, Wei Q, Winn DM, Shangina O, Pilarska A, Zhang ZF, Ferro G, Berthiller J, Boffetta P. Interaction between tobacco and alcohol use and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):541-50. doi: 10.1158/1055-9965.EPI-08-0347. Epub 2009 Feb 3.
  • Blot WJ, McLaughlin JK, Winn DM, Austin DF, Greenberg RS, Preston-Martin S, Bernstein L, Schoenberg JB, Stemhagen A, Fraumeni JF Jr. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Res. 1988 Jun 1;48(11):3282-7.
  • Chang ET, Adami HO. The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol Biomarkers Prev. 2006 Oct;15(10):1765-77. Review.
  • Klein G. Nasopharyngeal carcinoma (NPC) is an enigmatic tumor. Semin Cancer Biol. 2002 Dec;12(6):415-8.
  • Buell P. The effect of migration on the risk of nasopharyngeal cancer among Chinese. Cancer Res. 1974 May;34(5):1189-91.
  • Ozer E, Grecula JC, Agrawal A, Rhoades CA, Young DC, Schuller DE. Long-term results of a multimodal intensification regimen for previously untreated advanced resectable squamous cell cancer of the oral cavity, oropharynx, or hypopharynx. Laryngoscope. 2006 Apr;116(4):607-12.
  • Fallai C, Bolner A, Signor M, Gava A, Franchin G, Ponticelli P, Taino R, Rossi F, Ardizzoia A, Oggionni M, Crispino S, Olmi P. Long-term results of conventional radiotherapy versus accelerated hyperfractionated radiotherapy versus concomitant radiotherapy and chemotherapy in locoregionally advanced carcinoma of the oropharynx. Tumori. 2006 Jan-Feb;92(1):41-54.
  • Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.
  • Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.
  • Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.
  • Munro AJ. An overview of randomised controlled trials of adjuvant chemotherapy in head and neck cancer. Br J Cancer. 1995 Jan;71(1):83-91.
  • Akhlaghi F, Esmaeelinejad M, Shams A, Augend A. Evaluation of neo-adjuvant, concurrent and adjuvant chemotherapy in the treatment of head and neck squamous cell carcinoma: a meta-analysis. J Dent (Tehran). 2014 May;11(3):290-301. Epub 2014 May 31.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2019) 		482
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  • Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition).
  • No evidence of distant metastasis (M0).
  • Satisfactory performance status: Karnofsky scale (KPS) > 70.
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: creatinine clearance ≥60 ml/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age ≥65 years or <18 years.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jian Guan, Ph.D. +86-13632102247 51643930@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919552
Other Study ID Numbers  ICMJE LC2016PY015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jian Guan Nanfang Hospital of Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date April 2019

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

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