Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Completed; Phase 3

Conditions: Oropharynx Cancer; Hypopharynx Cancer; Larynx Cancer; Oral Cancer

Treatments: Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks; Procedure: Conventional radiotherapy 70 Gy in 7 weeks; Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks; Drug: 5FU, Paraplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00158652

GORTEC 99-02

Details and patient eligibility

About

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.

Full 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

Enrollment: 840 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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840 participants in 3 patient groups

1

Active Comparator group

Treatment:

Procedure: Conventional radiotherapy 70 Gy in 7 weeks

Drug: 5FU, Paraplatin

2

Experimental group

Treatment:

Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks

Drug: 5FU, Paraplatin

3

Experimental group

Treatment:

Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks