Palliative Radiotherapy Protocol in Head and Neck Cancer
Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study
1 other identifier
interventional
32
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2011
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedJune 2, 2015
May 1, 2015
3.8 years
May 26, 2015
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Toxicity (CTCAE v 4.0 graded)
from radiation treatment until 24 months planned follow-up or death
Other Outcomes (2)
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
Study Arms (1)
palliative radiation therapy
EXPERIMENTAL25 Gy in 5 daily fractions
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L4M1, Canada
Related Publications (1)
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.
PMID: 27020111DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Fortin, MD MSc
Maisonneuve Rosemont Hospital, University of Montreal
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 2, 2015
Study Start
June 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 2, 2015
Record last verified: 2015-05