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DAHANCA 37. Re-irradiation With Proton Radiotherapy

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ClinicalTrials.gov Identifier: NCT03981068
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Danish Head and Neck Cancer Group

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 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

Resource links provided by the National Library of Medicine


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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981068


Contacts
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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
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Principal Investigator: Kenneth Jensen Danish Centre for Particle Therapy
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Responsible Party: Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT03981068    
Other Study ID Numbers: Dahanca 37
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Danish Head and Neck Cancer Group:
recurrent
reirradiation
second primary
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nimorazole
Cisplatin
Antineoplastic Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents