TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer (Condor)

Radboud University Medical Center

Status and phase

Unknown

Phase 2

Conditions

Head and Neck Cancer

Treatments

Radiation: conventional radiotherapy with 'high' dose cisplatin

Radiation: accelerated radiotherapy with 'low' dose cisplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00774319

NWHHT08-01

Details and patient eligibility

About

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 patients are being randomised into two groups:

The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy
The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.

Full 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; prophylactic G-CSF

This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. In case of PD or SD (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol.

Surgery The investigators in each centre can decide neck surgery for residual tumor

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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