TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer (Condor)
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|ClinicalTrials.gov 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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- feasibility of both study-arms [ Time Frame: 2 years ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00774319
|Contact: C.M.L. van Herpen, Md, Phd||31 24 firstname.lastname@example.org|
|Netherlands Cancer Institute||Recruiting|
|Contact: J.P. de Boer 31 20 512 9111 email@example.com|
|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|
|Principal Investigator:||C.M.L. van Herpen, MD, Phd||UMCN st Radboud|