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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).


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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).


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility of both study-arms

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

C.M.L. van Herpen, MD, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMCN st Radboud

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

NWHHT08-01

NCT ID:

NCT00774319

Start Date:

December 2008

Completion Date:

April 2012

Related Keywords:

  • Head and Neck Cancer
  • HNSCC
  • neo Adjuvant
  • Chemoradiation therapy
  • TPF
  • Head and Neck Neoplasms

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