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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00774319
First received: October 16, 2008
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Head and Neck Cancer
 Radiation: conventional radiotherapy with 'high' dose cisplatin
Radiation: accelerated radiotherapy with 'low' dose cisplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • feasibility of both study-arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: 70
Study Start Date: December 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774319

Contacts
Contact: C.M.L. van Herpen, Md, Phd 31 24 3610353 c.vanherpen@onco.umcn.nl

Locations
Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands
Contact: J.P. de Boer    31 20 512 9111    j.d.boer@nki.nl   
Principal Investigator: J.P. de Boer         
University Medical Center Nijmegen st Radboud Recruiting
Nijmegen, Netherlands, 6525 GH
Principal Investigator: C.M.L van Herpen, Md, Phd         
Sponsors and Collaborators
Radboud University
Sanofi
Investigators
Principal Investigator: C.M.L. van Herpen, MD, Phd UMCN st Radboud
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00774319     History of Changes
Other Study ID Numbers: NWHHT08-01
Study First Received: October 16, 2008
Last Updated: April 10, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
HNSCC
neo Adjuvant
Chemoradiation therapy
TPF

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
 Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015