Palliative Radiotherapy Protocol in Head and Neck Cancer

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460471
• Other study ID #: 11020
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2015
• Last updated: June 1, 2015
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (2)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression free survival		from radiation treatment until 24 months planned follow-up or progression or death	No
Other	Overall survival		from radiation treatment until 24 months planned follow-up or death	No
Primary	Quality of life	EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H&N35 modules)	from radiation treatment until 24 months planned follow-up or death	No
Secondary	Toxicity (CTCAE v 4.0 graded)	CTCAE v 4.0 graded toxicities	from radiation treatment until 24 months planned follow-up or death	Yes