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出境医 / 临床实验 / DAHANCA 37. Re-irradiation With Proton Radiotherapy

DAHANCA 37. Re-irradiation With Proton Radiotherapy

Study Description
Brief Summary:

Summary Design Phase II observational

Treatment

  • 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx

    o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively

  • Proton radiotherapy
  • Concomitant cisplatin for eligible patients*
  • Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.

Endpoints

  • Primary:

    o Any new late toxicity grade >=3 according to CTC AE 5.0

  • Secondary

    • Side effects according to DAHANCA scoring system
    • Quality of life and PROM according to EORTC C30 and HN43
    • Loco-regional control (LRC)
    • Overall survival (OS)

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Radiation: Re-irradiation Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Re-Irradiation with protons
60 Gy in 50 fraktions, 10 weekly with protons
 Radiation: Re-irradiation
Cisplatin for all eligible patients, nimorazole for all SCC
Other Names:
  • cisplatin
  • nimorazole
Outcome Measures
Primary Outcome Measures :
  1. Any new grade >=3 toxicity [ Time Frame: 3 years after radiotherapy ]
    CTC AE 5.0


Secondary Outcome Measures :
  1. Side effects, any grade [ Time Frame: 5 years after radiotherapy ]
    According to CTC AE or Dahanca

  2. Quality of life and PROM [ Time Frame: 6 months ]
    EORTC QLQ HN43 , swallowing scale. Difference (mean) between baseline and 6 months

  3. Loco-regional control (LRC) [ Time Frame: 5 years after radiotherapy -actuarial analysis ]
    Abscence of locoregional failure

  4. Overall survival (OS) [ Time Frame: Median Survival up to 5 years ]
    Abscence of death


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

Inclusion Criteria:

  • Histological verified loco-regional recurrence or new primary
  • Available dose plan from primary radiotherapy course
  • Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
  • Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
  • Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
  • Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration

  • Absence of distant metastasis at both

    • clinical examination AND
    • PET-CT or CT of thorax and upper abdomen
  • Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
  • PS<=2 (WHO See appendix)

Exclusion Criteria:

  • Radical surgery (R0) and absence of adverse prognostic pathological features
  • Lymphoma or malignant melanoma
  • Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
  • As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Kenneth Jensen, PhD +45 21284108 kennjens@rm.dk
Contact: Jesper Eriksen, Professor jesper@oncology.au.dk

Locations
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Denmark
Danish Center for Particle Therapy Recruiting
Aarhus, Denmark, 8200
Contact: Kenneth Jensen, Ph.D.    78450000 ext 45    kennjens@rm.dk   
Contact: Dorte Winther, Nurse    78450000    dorte.skriver.winther@auh.rm.dk   
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Investigators
Layout table for investigator information
Principal Investigator: Kenneth Jensen Danish Centre for Particle Therapy
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019) 		Any new grade >=3 toxicity [ Time Frame: 3 years after radiotherapy ]
CTC AE 5.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Side effects, any grade [ Time Frame: 5 years after radiotherapy ]
    According to CTC AE or Dahanca
  • Quality of life and PROM [ Time Frame: 6 months ]
    EORTC QLQ HN43 , swallowing scale. Difference (mean) between baseline and 6 months
  • Loco-regional control (LRC) [ Time Frame: 5 years after radiotherapy -actuarial analysis ]
    Abscence of locoregional failure
  • Overall survival (OS) [ Time Frame: Median Survival up to 5 years ]
    Abscence of death
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 DAHANCA 37. Re-irradiation With Proton Radiotherapy
Official Title  ICMJE DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer
Brief Summary

Summary Design Phase II observational

Treatment

  • 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx

    o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively

  • Proton radiotherapy
  • Concomitant cisplatin for eligible patients*
  • Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.

Endpoints

  • Primary:

    o Any new late toxicity grade >=3 according to CTC AE 5.0

  • Secondary

    • Side effects according to DAHANCA scoring system
    • Quality of life and PROM according to EORTC C30 and HN43
    • Loco-regional control (LRC)
    • Overall survival (OS)
Detailed Description

Summary Design Phase II observational Inclusion criteria

  • Histological verified loco-regional recurrence or new primary
  • Available dose plan from primary radiotherapy course
  • Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
  • Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
  • Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
  • Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration

  • Absence of distant metastasis at both

    • clinical examination AND
    • PET-CT or CT of thorax and upper abdomen
  • Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
  • PS<=2 (WHO See appendix)

  • The patients should be able to read Danish in order to participate with quality of life questionnaires, but can participate in the rest of the protocol without being fluent in Danish, if capable of reading the patient information.

    * Complete Response is defined as the situation when a trained clinician, ideally at a multidisciplinary team conference, defines the patient as in complete remission, based on clinical examination and available imaging. This status can of course later be considered wrong as new information becomes available (sub-centimeter nodes grow etc.) Exclusion criteria

  • Radical surgery (R0) and absence of adverse prognostic pathological features
  • Lymphoma or malignant melanoma
  • Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
  • As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.

Treatment

  • 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx

    o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively

  • Proton radiotherapy
  • Concomitant cisplatin for eligible patients*
  • Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.

Endpoints

  • Primary:

    o Any new late toxicity grade >=3 according to CTC AE 5.0

  • Secondary

    • Side effects according to DAHANCA scoring system
    • Quality of life and PROM according to EORTC C30 and HN43
    • Loco-regional control (LRC)
    • Overall survival (OS)

Derived projects

  • Morbidity (NTCP) modeling for cumulative doses
  • Metrics for uncertainties regarding cumulative doses
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Neoplasms
Intervention  ICMJE Radiation: Re-irradiation
Cisplatin for all eligible patients, nimorazole for all SCC
Other Names:
  • cisplatin
  • nimorazole
Study Arms  ICMJE Experimental: Re-Irradiation with protons
60 Gy in 50 fraktions, 10 weekly with protons
Intervention: Radiation: Re-irradiation
Publications * Not Provided

*   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: June 7, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2025
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological verified loco-regional recurrence or new primary
  • Available dose plan from primary radiotherapy course
  • Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
  • Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
  • Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
  • Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration

  • Absence of distant metastasis at both

    • clinical examination AND
    • PET-CT or CT of thorax and upper abdomen
  • Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
  • PS<=2 (WHO See appendix)

Exclusion Criteria:

  • Radical surgery (R0) and absence of adverse prognostic pathological features
  • Lymphoma or malignant melanoma
  • Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
  • As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
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: Kenneth Jensen, PhD +45 21284108 kennjens@rm.dk
Contact: Jesper Eriksen, Professor jesper@oncology.au.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981068
Other Study ID Numbers  ICMJE Dahanca 37
Has Data Monitoring Committee No
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 Danish Head and Neck Cancer Group
Study Sponsor  ICMJE Danish Head and Neck Cancer Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Jensen Danish Centre for Particle Therapy
PRS Account Danish Head and Neck Cancer Group
Verification Date September 2020

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

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