NCT00158678

Brief Summary

This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
15 days until next milestone

Study Start

First participant enrolled

September 27, 2005

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

14.5 years

First QC Date

September 9, 2005

Last Update Submit

April 14, 2020

Conditions

Oral CancerOropharynx CancerHypopharynx Cancer

Keywords

oral canceroropharynx cancerhypopharynx cancerIMRT

Outcome Measures

Primary Outcomes (1)

  • Loco regional control

    2 years

Secondary Outcomes (3)

  • Survival

    2 years

  • Xerostomia at 2 years (evaluated by parotid gland scintigraphy)

    2 years

  • Quality of life (EORTC-QLQ-H&N35)

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Conventional RT 70Gy + concomitant cisplatin

Procedure: Conventional radiotherapy 70 GyDrug: concomitant cisplatin

2

EXPERIMENTAL

IMRT 75Gy + concomitant cisplatin

Procedure: IMRT 75 GyDrug: concomitant cisplatin

Interventions

IMRT 75 GyPROCEDURE

50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2

2
Conventional radiotherapy 70 GyPROCEDURE

50 Gy in PTV1 and 20 Gy in PTV2

1
concomitant cisplatinDRUG

100 mg/m2 D1, D22, D43

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
  • Stage III - IV (T1-T4, N0-N2)(UICC 2002)
  • Not resected
  • Indication of radiotherapy to bilateral cervical nodes at dose\>= 50 Gy
  • Delineation of target volumes done before randomization
  • Scintigraphy of parotid gland done before radiotherapy start
  • Quality of life questionnaires (EORTC-C30 and EORTC-H\&N35) filled in by the patient
  • Informed consent signed

You may not qualify if:

  • N3 (UICC 2002)
  • Distant metastasis
  • Contra-indication to concomitant cisplatin
  • History of cancer within the last 5 years
  • History of head and neck radiotherapy
  • Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

  • Tao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15.

    PMID: 32417348DERIVED

MeSH Terms

Conditions

Mouth NeoplasmsOropharyngeal NeoplasmsHypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jean Bourhis, PhD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

  • Michel Lapeyre, MD

    Centre Alexis Vautrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

September 27, 2005

Primary Completion

March 22, 2020

Study Completion

March 22, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

FR(2)