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Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Primary Purpose

Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Conventional radiotherapy 70 Gy in 7 weeks

middle accelerated radiotherapy 70 Gy in 6 weeks

very accelerated radiotherapy 64.8 Gy in 3.5 weeks

5FU, Paraplatin

About this trial

This is an interventional treatment trial for Oral Cancer focused on measuring Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU de Tours
Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Event free survival (event=progression, relapse, death from any cause)

Secondary Outcome Measures

Survival

Loco regional control

Toxicity

Full Information

NCT ID

NCT00158652

First Posted

September 9, 2005

Last Updated

November 7, 2011

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

1. Study Identification

Unique Protocol Identification Number

NCT00158652

Brief Title

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

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

March 2000 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer

Keywords

Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

840 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Conventional radiotherapy 70 Gy in 7 weeks

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

middle accelerated radiotherapy 70 Gy in 6 weeks

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

very accelerated radiotherapy 64.8 Gy in 3.5 weeks

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5FU, Paraplatin

Intervention Description

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)

Primary Outcome Measure Information:

Title

Event free survival (event=progression, relapse, death from any cause)

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Survival

Time Frame

3 years

Title

Loco regional control

Time Frame

3 years

Title

Toxicity

Time Frame

early and late

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Bourhis, PhD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gilles Calais

Organizational Affiliation

CHU Tours

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Tours

City

Tours

ZIP/Postal Code

37 044

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94800

Country

France

12. IPD Sharing Statement

Learn more about this trial

Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

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