Clinical trial NCT00158652: Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
Official title: Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Cancer
Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Keywords: Head and neck squamous cell carcinoma
Radiotherapy
Chemotherapy
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 840
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.

Detailed description: This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival.

The treatments are

Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46

Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33

* first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy
* second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day)

Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy

Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
* Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
* Not resectable
* Karnofsky PS \>= 70
* Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
* Informed consent signed

Exclusion Criteria:

* Distant metastasis
* Contra-indication to concomitant chemotherapy
* History of cancer
* History of head and neck radiotherapy

Primary outcomes:
measure: Event free survival (event=progression, relapse, death from any cause)
timeFrame: 3 years
Secondary outcomes:
measure: Survival
timeFrame: 3 years
measure: Loco regional control
timeFrame: 3 years
measure: Toxicity
timeFrame: early and late
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU de Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Jean Bourhis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Tours
name: Gilles Calais
role: PRINCIPAL_INVESTIGATOR
References: