TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer (Condor)
This study is currently recruiting participants.
Verified April 2012 by Radboud University
Sponsor:
Radboud University
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
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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:
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
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 by Site Neoplasms Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013