Palliative Radiotherapy Protocol in Head and Neck Cancer

Maisonneuve-Rosemont Hospital

Status and phase: Completed; Phase 2

Conditions: Quality of Life; Head and Neck Neoplasms

Treatments: Radiation: palliative radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02460471

11020 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

palliative radiation therapy

Experimental group

Description:

25 Gy in 5 daily fractions

Treatment:

Radiation: palliative radiation therapy