Palliative Radiotherapy Protocol in Head and Neck Cancer

June 1, 2015 updated by: Bernard Fortin MD MSc FRCPC, Maisonneuve-Rosemont Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H2L4M1
        • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: from radiation treatment until 24 months planned follow-up or death
EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H&N35 modules)
from radiation treatment until 24 months planned follow-up or death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity (CTCAE v 4.0 graded)
Time Frame: from radiation treatment until 24 months planned follow-up or death
CTCAE v 4.0 graded toxicities
from radiation treatment until 24 months planned follow-up or death

Other Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: from radiation treatment until 24 months planned follow-up or progression or death
from radiation treatment until 24 months planned follow-up or progression or death
Overall survival
Time Frame: from radiation treatment until 24 months planned follow-up or death
from radiation treatment until 24 months planned follow-up or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11020 (DAIDS ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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