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Completed

NCT Number: NCT02460471

Palliative Radiotherapy Protocol in Head and Neck Cancer

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Radiation Therapy

Radiation

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 outcomes

  1. 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)

Secondary outcomes

  1. 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

Other outcomes

  1. Progression free survival

    Time frame: from radiation treatment until 24 months planned follow-up or progression or death

  2. Overall survival

    Time frame: from radiation treatment until 24 months planned follow-up or death

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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