Clinical trial NCT00162708: Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC
Official title: A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Oropharynx Cancer
Oral Cancer
Hypopharynx Cancer
Larynx Cancer
Keywords: Head and neck squamous cell carcinoma
Radiotherapy
Chemotherapy
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Detailed description: Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (\> 50%) to the initial course of RT-CT. The end points were event free survival and survival.

Eligibility criteria: Inclusion Criteria:

* palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
* primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
* performance status of 0 to 2 (WHO scoring system)
* renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
* signed inform consent

Exclusion Criteria:

* distant metastasis
* previous history of cancer
* previous radiotherapy or chemotherapy

Primary outcomes:
measure: Event free survival (event = progressive disease or relapse or or death from any cause)
Secondary outcomes:
measure: Survival
measure: Toxicity
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Jean Bourhis
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Alexis Vautrin
name: Michel Lapeyre
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Jean Perrin
name: Jacques Tortochaux
role: PRINCIPAL_INVESTIGATOR
References: