Palliative Radiotherapy Protocol in Head and Neck Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02460471

Enrollment

Registered

2015-06-02

Start date

2011-06-30

Completion date

2015-04-30

Last updated

2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms, Quality of Life

Keywords

Radiotherapy, Palliative Care, IMRT

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.

Interventions

RADIATIONpalliative 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Other

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026