DAHANCA 37. Re-irradiation With Proton Radiotherapy

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981068
• Other study ID #: Dahanca 37
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 30, 2025

Study information

• Verified date: September 2020
• Source: Danish Head and Neck Cancer Group
• Contact: Kenneth Jensen, PhD
• Phone: +45 21284108
• Email: kennjens[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Radiation:
• Re-irradiation
Cisplatin for all eligible patients, nimorazole for all SCC

Locations

Country	Name	City	State
Denmark	Danish Center for Particle Therapy	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any new grade >=3 toxicity	CTC AE 5.0	3 years after radiotherapy
Secondary	Side effects, any grade	According to CTC AE or Dahanca	5 years after radiotherapy
Secondary	Quality of life and PROM	EORTC QLQ HN43 , swallowing scale. Difference (mean) between baseline and 6 months	6 months
Secondary	Loco-regional control (LRC)	Abscence of locoregional failure	5 years after radiotherapy -actuarial analysis
Secondary	Overall survival (OS)	Abscence of death	Median Survival up to 5 years