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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 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:

MedlinePlus related topics: Head and Neck Cancer

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 ]

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 ]


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 (Adult)
Sexes Eligible for Study:	All
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Driessen CM, de Boer JP, Gelderblom H, Rasch CR, de Jong MA, Verbist BM, Melchers WJ, Tesselaar ME, van der Graaf WT, Kaanders JH, van Herpen CM. Induction chemotherapy with docetaxel/cisplatin/5-fluorouracil followed by randomization to two cisplatin-based concomitant chemoradiotherapy schedules in patients with locally advanced head and neck cancer (CONDOR study) (Dutch Head and Neck Society 08-01): A randomized phase II study. Eur J Cancer. 2016 Jan;52:77-84. doi: 10.1016/j.ejca.2015.09.024. Epub 2015 Dec 1.


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

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

ClinicalTrials.gov processed this record on August 16, 2017

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