NCT00273546|CompletedPhase 3

Induction Chemotherapy Comparing Taxotere® Cisplatin and 5-Fluorouracil (TPF) With Standard Cisplatin and 5-Fluorouracil (PF) Followed by Chemoradiation in Locally Advanced Head and Neck Cancer

A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere®) Plus Cisplatin and 5-Fluorouracil (TPF) Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil Followed by Concomitant Chemoradiotherapy to Improve the Overall Survival and Progression Free Survival in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

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2 other identifiers

EFC6043RP-56976-V-324

Study Type

interventional

Target

500

Locations

6 countries

Sites

Timeline

RegisteredJan 2006

StartedMay 1999

CompletionFeb 2006

Brief Summary

1.To compare overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5FU) or the control treatment (PF: cisplatin plus 5-FU) followed by chemoradiotherapy in patients with locally advanced SCCHN.
2.The main secondary endpoint is progression free survival (PFS). The other secondary endpoints are to evaluate and compare improvement of local symptoms; time-to-treatment failure; quality of life; clinical complete response rate (CR and CR/PR); toxicity and to evaluate the relationship of tumor markers and response to therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

500

participants targeted

Target at P75+ for phase_3 cancer

Timeline

Completed

Started May 1999

Longer than P75 for phase_3 cancer

Geographic Reach

6 countries

6 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

6.8 years study duration

Study Start

First participant enrolled

May 1, 1999

Completed

6.7 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed

23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed

Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

6.8 years

First QC Date

January 6, 2006

Last Update Submit

April 28, 2009

Conditions

Cancer

Keywords

Head and Neck CancerInductionChemotherapyChemoradiotherapy

Outcome Measures

Primary Outcomes (1)

Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.

Secondary Outcomes (4)

The main secondary outcome is progression free survival (PFS).
The other secondary endpoints are improvement of local symptoms;time-to-treatment failure;quality of life;
clinical complete response rate (CR) and overall response rate(PR+CR) after chemotherapy and after locoregional therapy(chemoradiotherapy);
duration of response(CR and CR+PR); toxicity.

Interventions

XRP6976 (Docetaxel/Taxotere)DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically or cytologically proven squamous cell carcinoma of the head/neck.
Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx, larynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: nasal, paranasal cavities; nasopharynx.
Stage 3 or 4 disease without evidence of distant metastases verified with Chest X-Ray, abdominal ultrasound or CT (liver function test abnormalities); bone scan in case of local symptoms.
At least one uni or bidimensionally measurable lesion.
Tumor considered as inoperable after evaluation by a multidisciplinary team (surgeon, medical oncologist and radiation oncologist). Criteria include : Technical unresectablility-ie tumor fixation/invasion to base of the skull or cervical vertebrae involvement of the nasopharynx and fixed lymph nodes; Physician's decision based on low surgical curability which includes all T3-4 stages, all N2-3 stages excluding T1N2; organ preservation.
No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry.
Age ³ 18 years.
WHO performance status of 0-1
No active alcohol addiction
Life expectancy ³ 12 weeks
Signed informed consent prior to beginning protocol specific procedures
Adequate bone marrow, hepatic and renal functions as evidenced by the following: Hematology (Bone Marrow): Neutrophil count ³ 2.0 x 10 9/L; Platelet count ³ 100 X 10 9/L; Hemoglobin ³ 10g/dL; Hepatic function : Total bilirubin WNL; ASAT (SGOT) and ALAT (SGPT) £ 2.5 X ULN; Alkaline phosphatase £ 5 X ULN; patients with ASAT or ALAT \> 1.5 x ULN associated with alkaline phosphatase \> 2.5 x ULN are not eligible for the study; Renal function: the creatinine clearance ³ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows: Weight (kg) X (140-age)/K x serum creatinine.
Patients must be available for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.

You may not qualify if:

Pregnant or lactating women or women of childbearing potential not using adequate contraception.
Symptomatic peripheral neuropathy ³ grade 2 by NCIC-CTG criteria.
Symptomatic altered hearing \> grade 2 by NCIC-CTG criteria.
Other serious illnesses or medical conditions including but no limited to: Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; History of significant neurologic or psychiatric disorders including dementia or seizures; Active uncontrolled infection; Active peptic ulcer; Hypercalcemia; Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
Patients requiring intravenous alimentation.
Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.
Concurrent treatment with any other anticancer therapy
Participation in an investigational trial within 30 days of study entry.

Contact the study team to confirm eligibility.