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

April 10, 2012 updated by: Radboud University Medical Center

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).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Netherlands Cancer Institute
        • Contact:
        • Principal Investigator:
          • J.P. de Boer
      • Nijmegen, Netherlands, 6525 GH
        • Recruiting
        • University Medical Center Nijmegen st Radboud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Induction Chemotherapy with TPF Then: cisplatin 100 mg/m2 on day 1, 22 and 43 combined with conventional radiotherapy
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
ACTIVE_COMPARATOR: 2
Induction chemotherapy with TPF Then cisplatin 40mg/m2 on day 1,8,15,22,29 and 35 combined with accelerated radiotherapy
Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
feasibility of both study-arms
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
to assess the toxicity profile, tumour response, disease free survival and overall survival in both study-arms. Also QoL will be measured.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ANTICIPATED)

April 1, 2012

Study Completion (ANTICIPATED)

April 1, 2012

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (ESTIMATE)

October 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NWHHT08-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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