Reirradiation With Concomitant Chemotherapy After Salvage... | NCT00180934 | Trialant

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Reirradiation With Concomitant Chemotherapy After Salvage... | NCT00180934 | Trialant

Studies
Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

NCT00180934

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Dec 23, 2005Estimated

Enrollment

280

Phase

Phase 3

Conditions

Recurrence of Head and Cancer in Irraiated Area

Interventions

Reirradiation with concomitant chemotherapy

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

NCT00180934

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

JANORL

Secondary IDs

ID	Type	Description	Link
CSET 98/656

Brief Title

Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Official Title

Interest of a Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area: a Multicentric Phase III Randomized Trial

Acronym

Not provided

Organization

Gustave Roussy, Cancer Campus, Grand ParisOTHER

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jul 1999

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 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

Dec 22, 2005

Last Update Posted Date

Dec 23, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Gustave Roussy, Cancer Campus, Grand ParisOTHER

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

Interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial

Detailed Description

Not provided

Conditions Module

Conditions

Recurrence of Head and Cancer in Irraiated Area

Keywords

Not provided

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

280

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reirradiation with concomitant chemotherapy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival at 3 years

Secondary Outcomes

Measure	Description	Time Frame
Local event-free survival
Toxicity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

head and neck squamous cancer
both sexes
>=18 years
recurrence treated by surgery and initially treated by radiotherapy
with written informed consent at entry time

Exclusion Criteria:

-

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François JANOT, MD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif		94800	France

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

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

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Diagnostic

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

ID	Term
D000069475	Re-Irradiation

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D019233	Retreatment

Browse Leaves

Not provided

Browse Branches

Not provided