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DAHANCA 37. Re-irradiation With Proton Radiotherapy

NCT03981068 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-25

No results posted yet for this study

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)

Conditions

  • Head and Neck Neoplasms

Interventions

RADIATION

Re-irradiation

Cisplatin for all eligible patients, nimorazole for all SCC

Sponsors & Collaborators

  • Danish Head and Neck Cancer Group

    lead NETWORK

Principal Investigators

  • Kenneth Jensen · Danish Centre for Particle Therapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-08-30
Completion
2025-08-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03981068 on ClinicalTrials.gov