Accelerated Radiotherapy and Concomitant Chemo-radiothera... | NCT00158652

Studies
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

NCT00158652

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Status

Completed

Last Update Posted

Nov 8, 2011Estimated

Enrollment

840Actual

Phase

Phase 3

Conditions

Oral Cancer
Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2000

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2011

Last Update Posted Date

Nov 8, 2011Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

840Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Active Comparator	Procedure: Conventional radiotherapy 70 Gy in 7 weeks Drug: 5FU, Paraplatin
2	Experimental	Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks Drug: 5FU, Paraplatin
3	Experimental	Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional radiotherapy 70 Gy in 7 weeks	Procedure	2 gy per fraction, 1 fraction per day, 5 fractions per week	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event free survival (event=progression, relapse, death from any cause)		3 years

Secondary Outcomes

Measure	Description	Time Frame
Survival		3 years
Loco regional control		3 years
Toxicity

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Bourhis, PhD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator
Gilles Calais	CHU Tours	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Tours		Tours		37 044	France
Institut Gustave Roussy

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D009062	Mouth Neoplasms
D009959	Oropharyngeal Neoplasms
D007012	Hypopharyngeal Neoplasms
D007822	Laryngeal Neoplasms
D000077195	Squamous Cell Carcinoma of Head and Neck

Ancestor Terms

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D010608	Pharyngeal Diseases
D010038	Otorhinolaryngologic Diseases
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases
D012142	Respiratory Tract Neoplasms
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D005472	Fluorouracil
D016190	Carboplatin

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals