Status:
UNKNOWN
TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Sanofi
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer: All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU). Subsequently ...
Detailed Description
Induction Chemotherapy TPF(arm A and B) : Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv continuous infusion (in Hickman or port a cath) on days 1-5; prophyla...
Eligibility Criteria
Inclusion
- Histology and staging disease
- Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy
- Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation
- Measurable disease
- Primary site: oral cavity, oropharynx, hypopharynx and larynx
- General conditions
- Written informed consent
- Age \>18 years and ≤ 65 years
- WHO performance status 0-1
- Adequate bone marrow function (WBC \> 3.0 x 109/L, platelets \> 100 x 109/L, Hb \> 6 mmol/L)
- Adequate hepatic function: total bilirubin \< 1. 5 x upper normal limit, ASAT and ALAT \< 2.5 x upper normal limits
- Adequate renal function: calculated creatinin clearance \> 60ml/min. (Cockcroft-Gault formula) Other
- Expected adequacy of follow-up.
Exclusion
- General conditions
- Active alcohol addiction
- Admission for COPD in the last 12 months
- Weight loss \> 10% in 3 months before entry
- Pregnancy or lactation
- Patients (M/F) with reproductive potential not implementing adequate contraceptives measures
- Prior or current history
- Prior surgery, radiotherapy or chemotherapy for this tumor
- Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments
- Serious active infections
- Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin
- Concomitant treatments
- Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
- Concurrent treatment with any other anti-cancer therapy
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00774319
Start Date
December 1 2008
End Date
April 1 2012
Last Update
April 11 2012
Active Locations (2)
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1
Netherlands Cancer Institute
Amsterdam, Netherlands
2
University Medical Center Nijmegen st Radboud
Nijmegen, Netherlands, 6525 GH