Palliative Radiotherapy Protocol in Head and Neck Cancer

Sponsor

Maisonneuve-Rosemont Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02460471

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms Quality of Life	Radiation: palliative radiation therapy	Phase 2

Detailed Description

Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: palliative radiation therapy 25 Gy in 5 daily fractions	Radiation: palliative radiation therapy thermoplastic mask immobilization. CT in treatment position. radiation dose of 25 Gy in 5 daily fractions over one week 6 MV photons by intensity modulation. Target volume is the symptomatic tumour volume with a 5 mm margin

Arm

Intervention/Treatment

Experimental: palliative radiation therapy

25 Gy in 5 daily fractions

Radiation: palliative radiation therapy

thermoplastic mask immobilization. CT in treatment position. radiation dose of 25 Gy in 5 daily fractions over one week 6 MV photons by intensity modulation. Target volume is the symptomatic tumour volume with a 5 mm margin

Outcome Measures

Primary Outcome Measures

Quality of life [from radiation treatment until 24 months planned follow-up or death]
EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H&N35 modules)

Secondary Outcome Measures

Toxicity (CTCAE v 4.0 graded) [from radiation treatment until 24 months planned follow-up or death]
CTCAE v 4.0 graded toxicities

Other Outcome Measures

Progression free survival [from radiation treatment until 24 months planned follow-up or progression or death]
Overall survival [from radiation treatment until 24 months planned follow-up or death]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Able to give an informed consent
Able to complete QOL questionnaires
Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy
Presence of measurable disease
Biopsy proven squamous or salivary cancer of the head and neck region
Expected survival of at least 2 months.

Exclusion Criteria:

Pregnancy
No previous RT to the neck and no plan to receive concomitant chemotherapy
Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region)
Unavailable for follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 2M4
2	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec	Canada	H2L4M1

Sponsors and Collaborators

Maisonneuve-Rosemont Hospital
Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Principal Investigator: Bernard Fortin, MD MSc, Maisonneuve Rosemont Hospital, University of Montreal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bernard Fortin MD MSc FRCPC, principal investigator, Maisonneuve-Rosemont Hospital

ClinicalTrials.gov Identifier:

NCT02460471

Other Study ID Numbers:

11020

First Posted:

Jun 2, 2015

Last Update Posted:

Jun 2, 2015

Last Verified:

May 1, 2015

Keywords provided by Bernard Fortin MD MSc FRCPC, principal investigator, Maisonneuve-Rosemont Hospital

Radiotherapy

Palliative Care

IMRT

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Jun 2, 2015