Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Oral Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158652
• Other study ID #: GORTEC 99-02
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: November 7, 2011
• Start date: March 2000
• Est. completion date: March 2011

Study information

• Verified date: November 2011
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Hypopharynx Cancer
• Larynx Cancer
• Oral Cancer
• Oropharynx Cancer

Intervention

Procedure:
• Conventional radiotherapy 70 Gy in 7 weeks
2 gy per fraction, 1 fraction per day, 5 fractions per week
• 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
• 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)

Locations

Country	Name	City	State
France	CHU de Tours	Tours
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival (event=progression, relapse, death from any cause)		3 years	No
Secondary	Survival		3 years	No
Secondary	Loco regional control		3 years	No
Secondary	Toxicity		early and late	Yes

External Links

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