NCT00158652

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2000

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

Study Start

First participant enrolled

March 1, 2000

Completed
5.5 years until next milestone

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
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

11 years

First QC Date

September 9, 2005

Last Update Submit

November 7, 2011

Conditions

Oral CancerOropharynx CancerHypopharynx CancerLarynx Cancer

Keywords

Head and neck squamous cell carcinomaRadiotherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (3)

  • Survival

    3 years

  • Loco regional control

    3 years

  • Toxicity

    early and late

Study Arms (3)

1

ACTIVE COMPARATOR
Procedure: Conventional radiotherapy 70 Gy in 7 weeksDrug: 5FU, Paraplatin

2

EXPERIMENTAL
Procedure: middle accelerated radiotherapy 70 Gy in 6 weeksDrug: 5FU, Paraplatin

3

EXPERIMENTAL
Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks

Interventions

Conventional radiotherapy 70 Gy in 7 weeksPROCEDURE

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

1
middle accelerated radiotherapy 70 Gy in 6 weeksPROCEDURE

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

2
very accelerated radiotherapy 64.8 Gy in 3.5 weeksPROCEDURE

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

3
5FU, ParaplatinDRUG

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)

12

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Distant metastasis
  • Contra-indication to concomitant chemotherapy
  • History of cancer
  • History of head and neck radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Tours

Tours, 37 044, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Mouth NeoplasmsOropharyngeal NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

FluorouracilCarboplatin

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Jean Bourhis, PhD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

  • Gilles Calais

    CHU Tours

    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

March 1, 2000

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

FR(2)