DAHANCA 37. Re-irradiation With Proton Radiotherapy

NCT03981068 | Unknown

• 1 other identifier: Dahanca 37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Head and Neck Neoplasms

Keywords

recurrent; reirradiation; second primary

Outcome Measures

Primary Outcomes (1)

• Any new grade >=3 toxicity

  CTC AE 5.0

  3 years after radiotherapy

Secondary Outcomes (4)

• Side effects, any grade

  5 years after radiotherapy

• Quality of life and PROM

  6 months

• Loco-regional control (LRC)

  5 years after radiotherapy -actuarial analysis

• Overall survival (OS)

  Median Survival up to 5 years

Study Arms (1)

Re-Irradiation with protons

EXPERIMENTAL

60 Gy in 50 fraktions, 10 weekly with protons

Radiation: Re-irradiation

Interventions

Re-irradiation RADIATION

Cisplatin for all eligible patients, nimorazole for all SCC

Also known as: cisplatin, nimorazole

Re-Irradiation with protons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Head and Neck Cancer Group: lead

Study Sites (1)

Danish Center for Particle Therapy

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence

Interventions

Re-Irradiation; Cisplatin; Nimorazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Retreatment; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kenneth Jensen

  Danish Centre for Particle Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Jensen, PhD

CONTACT

+45 21284108; kennjens@rm.dk

Jesper Eriksen, Professor

CONTACT

jesper@oncology.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 10, 2019
• Study Start: September 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2025
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)