Palliative Radiotherapy Protocol in Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Neoplasms; Quality of Life
• Interventions: Radiation: palliative radiation therapy

• Registration Number: NCT02460471
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

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 Timeline

• Study Start: 2011-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-01
• Last Update Submitted: 2015-06-01
• Study First Posted: 2015-06-02
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
palliative radiation therapy	palliative radiation therapy	25 Gy in 5 daily fractions

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada