Spots Global Cancer Trial Database for TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer

Official Title: A Randomised Study of TPF as Neoadjuvant Chemotherapy Followed by Concomitant Chemoradiotherapy (CRT) With Conventional Radiotherapy (RT) Versus Concomitant CRT With Accelerated RT in Patients With Locally Advanced Head and Neck Squamous Cell Cancer (HNSCC) in Good Condition. The Condor Study. A Study of the Dutch Head and Neck Cancer Group (DHNCG).

Study ID: NCT00774319

Conditions

Head and Neck Cancer

Interventions

conventional radiotherapy with 'high' dose cisplatin

accelerated radiotherapy with 'low' dose cisplatin

Study Description

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 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.

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; 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