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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-18

Study Completion Date

2020-06-05

Brief Summary

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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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Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Radiotherapy

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard RT

70 Gy / 7 weeks / 2 Gy per fraction

Group Type ACTIVE_COMPARATOR

Standard RT

Intervention Type RADIATION

70 Gy / 7 weeks / 2 Gy per fraction

Hypofractionated RT

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

Group Type EXPERIMENTAL

Hypofractionated RT

Intervention Type 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

Interventions

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Standard RT

70 Gy / 7 weeks / 2 Gy per fraction

Intervention Type RADIATION

Hypofractionated RT

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No