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

Head and Neck Cancer Clinical Trial

— Condor  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00774319
• Other study ID #: NWHHT08-01
• Status: Recruiting
• Phase: Phase 2
• First received: October 16, 2008
• Last updated: April 10, 2012
• Start date: December 2008
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Radboud University
• Contact: C.M.L. van Herpen, Md, Phd
• Phone: 31 24 3610353
• Email: c.vanherpen[@]onco.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• conventional radiotherapy with 'high' dose cisplatin
radiotherapy: 5 fractions/week, total treatment time 7 weeks. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions. 100 mg/m2 cisplatin iv on day 1, 22 and 43
• accelerated radiotherapy with 'low' dose cisplatin
Accelerated radiotherapy 6 fractions/week, total treatment time 6 weeks. During one of the weekdays two fractions will be delivered with an interval of at least 6h. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions cisplatin 40 mg/m2 iv on day 1,8,18,22,29,35

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	University Medical Center Nijmegen st Radboud	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of both study-arms		2 years	No
Secondary	to assess the toxicity profile, tumour response, disease free survival and overall survival in both study-arms. Also QoL will be measured.		2 years	No