Trial | NCT00158652  Report issue

Title

Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluorouracil carboplatin ...

  • Study Participants

    840
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.
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
Study Started
Mar 31
2000
Primary Completion
Mar 31
2011
Study Completion
Mar 31
2011
Last Update
Nov 08
2011
Estimate

Procedure Conventional radiotherapy 70 Gy in 7 weeks

2 gy per fraction, 1 fraction per day, 5 fractions per week

Procedure middle accelerated radiotherapy 70 Gy in 6 weeks

5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks

Procedure very accelerated radiotherapy 64.8 Gy in 3.5 weeks

2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks

Drug 5FU, Paraplatin

5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)

1 Active Comparator

2 Experimental

3 Experimental

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
No Results Posted