Overview

Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Treatments:
Carboplatin
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