Status:
COMPLETED
Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Collaborating Sponsors:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief Summary
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interrup...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT01864850
Start Date
October 18 2013
End Date
June 5 2020
Last Update
September 22 2023
Active Locations (2)
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1
Institut Gustave Roussy
Villejuif, France, 94805
2
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98 000