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Completed

NCT Number: NCT01864850

Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC

Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Gustave Roussy, Villejuif, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 70 or over
  • SIOG group 2 (vulnerable)
  • Life expectancy > 12 weeks
  • PS < 2
  • Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
  • First line treatment
  • At least one measurable lesion (RECIST)
  • Stage II to IV
  • Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized
  • Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area
  • Consent form signed

Exclusion criteria

  • Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
  • Stage I cancer
  • Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
  • Prior radiotherapy of head and neck area
  • Concurrent chemotherapy or immunotherapy or hormonotherapy
  • Induction chemotherapy
  • Concomitant infection requiring IV antibiotics
  • cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)
  • conditions that could lead to bad compliance

Treatment and study plan

Standard RT

Radiation

70 Gy / 7 weeks / 2 Gy per fraction

Hypofractionated RT

Radiation

55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy

Primary outcomes

  1. Locoregional control

    Time frame: 6 months

    Patient alive with locoregional control at 6 months after the end of radiotherapy

Secondary outcomes

  1. Acute toxicity

    Time frame: 3 months

    Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade

  2. Late toxicity

    Time frame: 18 months

    Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade

  3. Autonomy

    Time frame: 18 months

    Autonomy according to ADL scale

  4. Health related quality of life

    Time frame: 18 months

    Quality of life according to EORTC QLQ-C30 and QLQ-HN35

  5. Overall survival

    Time frame: 18 months

    Overall survival

  6. Locoregional progression

    Time frame: 18 months

    Locoregional progression

  7. metastasis progression

    Time frame: 18 months

    metastasis progression

  8. Progression free survival

    Time frame: 18 months

    Progression free survival

Sponsors and collaborators

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Other

Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

Registry information

Official study title

Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma

Acronym: ELAN-RT

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
May 30, 2013
Registry last updated
Sep 22, 2023

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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