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Palliative Radiotherapy Protocol in Head and Neck Cancer

Primary Purpose

Head and Neck Neoplasms, Quality of Life

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
palliative radiation therapy
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Radiotherapy, Palliative Care, IMRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

palliative radiation therapy

Arm Description

25 Gy in 5 daily fractions

Outcomes

Primary Outcome Measures

Quality of life
EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H&N35 modules)

Secondary Outcome Measures

Toxicity (CTCAE v 4.0 graded)
CTCAE v 4.0 graded toxicities

Full Information

First Posted
May 26, 2015
Last Updated
June 1, 2015
Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT02460471
Brief Title
Palliative Radiotherapy Protocol in Head and Neck Cancer
Official Title
Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Quality of Life
Keywords
Radiotherapy, Palliative Care, IMRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
palliative radiation therapy
Arm Type
Experimental
Arm Description
25 Gy in 5 daily fractions
Intervention Type
Radiation
Intervention Name(s)
palliative radiation therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of life
Description
EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H&N35 modules)
Time Frame
from radiation treatment until 24 months planned follow-up or death
Secondary Outcome Measure Information:
Title
Toxicity (CTCAE v 4.0 graded)
Description
CTCAE v 4.0 graded toxicities
Time Frame
from radiation treatment until 24 months planned follow-up or death
Other Pre-specified Outcome Measures:
Title
Progression free survival
Time Frame
from radiation treatment until 24 months planned follow-up or progression or death
Title
Overall survival
Time Frame
from radiation treatment until 24 months planned follow-up or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Fortin, MD MSc
Organizational Affiliation
Maisonneuve Rosemont Hospital, University of Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27020111
Citation
Fortin B, Khaouam N, Filion E, Nguyen-Tan PF, Bujold A, Lambert L. Palliative Radiation Therapy for Advanced Head and Neck Carcinomas: A Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):647-53. doi: 10.1016/j.ijrobp.2016.01.039. Epub 2016 Jan 28.
Results Reference
derived

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Palliative Radiotherapy Protocol in Head and Neck Cancer

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