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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774319
Recruitment Status : Unknown
Verified April 2012 by Radboud University.
Recruitment status was:  Recruiting
First Posted : October 17, 2008
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):
Radboud University

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.

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : December 2008
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

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

Primary Outcome Measures :
  1. feasibility of both study-arms [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774319

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Contact: C.M.L. van Herpen, Md, Phd 31 24 3610353

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Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands
Contact: J.P. de Boer    31 20 512 9111   
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
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Principal Investigator: C.M.L. van Herpen, MD, Phd UMCN st Radboud
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Radboud University Identifier: NCT00774319    
Other Study ID Numbers: NWHHT08-01
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012
Keywords provided by Radboud University:
neo Adjuvant
Chemoradiation therapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents