Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005527

Trial Description

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Title

A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere) Plus Cisplatin Plus 5-Fluorouracil Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining more than one drug and combining chemotherapy with radiation therapy may
kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more
effective for advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of
combination chemotherapy plus radiation therapy in treating patients who have advanced head
and neck cancer.

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Brief Summary in Scientific Language

OBJECTIVES: I. Compare the progression free survival of patients with locally advanced,
inoperable squamous cell carcinoma of the head and neck treated with cisplatin plus
fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy. II. Compare the
response rate, response duration, toxicity, local symptoms, and time to disease progression
of these treatment regimens in this patient population. III. Evaluate the quality of life in
these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
primary tumor site (oral cavity vs oropharynx vs hypopharynx vs larynx) and institution.
Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV
over 1 hour, immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil
(5-FU) IV as a continuous infusion on days 1-5. Arm II: Patients receive cisplatin IV over 1
hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5. Treatment continues
every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course.
Radiotherapy is administered 5 days a week for up to 7 weeks. Quality of life is assessed
before treatment, at courses 2 and 4, and at 6 and 9 months. Patients are followed every 3
months for the first 2 years and then every 6 months until death.

PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study within 24 months.

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Organizational Data

  •   DRKS00005527
  •   2014/02/18
  •   1999/11/01
  •   yes
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Secondary IDs

  •   NCT00003888  (ClinicalTrials.gov)
  •   EORTC-24971  (European Organisation for Research and Treatment of Cancer - EORTC)
  •   RP-56976-V-323 
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Health Condition or Problem studied

  •   Head and Neck Cancer
  •   C01 -  Malignant neoplasm of base of tongue
  •   C02 -  Malignant neoplasm of other and unspecified parts of tongue
  •   C03 -  Malignant neoplasm of gum
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C05 -  Malignant neoplasm of palate
  •   C06 -  Malignant neoplasm of other and unspecified parts of mouth
  •   C10 -  Malignant neoplasm of oropharynx
  •   C13 -  Malignant neoplasm of hypopharynx
  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   Drug: cisplatin
  •   Drug: docetaxel
  •   Drug: fluorouracil
  •   Radiation: radiation therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
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  •   Treatment
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  •   III
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Primary Outcome

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Secondary Outcome

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Countries of Recruitment

  •   Austria
  •   Belgium
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  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Italy
  •   Netherlands
  •   Poland
  •   Slovakia
  •   Spain
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   1999/04/30
  •   359
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven locally advanced squamous
cell carcinoma of the head and neck Stage III or IV without distant metastases
Unresectable Primary tumor sites: Oral cavity Oropharynx Hypopharynx Larynx Must have at
least one measurable lesion

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at
least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than upper
limit of normal (ULN) SGOT and SGPT no greater than 2.5 times ULN Alkaline phosphatase no
greater than 5 times ULN No SGOT and SGPT greater than 1.5 times ULN AND alkaline
phosphatase greater than 2.5 times ULN Renal: Creatinine no greater than 1.4 mg/dL OR
Creatinine clearance at least 60 mL/min Cardiovascular: At least 6 months since prior
myocardial infarction No unstable, treated cardiac disease Pulmonary: At least one year
since prior hospitalization for chronic obstructive pulmonary disease Neurologic: No
neurologic or psychiatric disorders (e.g., dementia or seizures) No concurrent peripheral
neuropathy greater than grade 1 Other: No active uncontrolled infection No active peptic
ulcer No alteration in hearing At least 5 years since any other neoplastic disease except
curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or
other cancer curatively treated by surgery Not pregnant or nursing Fertile patients must
use effective contraception No other psychological, familial, sociological, or
geographical condition that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: No primary prophylactic colony stimulating
factors during the first course of therapy Chemotherapy: No prior or concurrent
chemotherapy Endocrine therapy: At least 3 weeks since prior corticosteroid No chronic
corticosteroid therapy (greater than 3 months) Radiotherapy: No prior radiotherapy
Surgery: No prior surgery for this cancer Other: At least 30 days since prior treatment in
a clinical trial No concurrent use of drugs that interact with fluorouracil (e.g.,
cimetidine, allopurinol, folic acid or leucovorin calcium) No other concurrent
investigational drugs or anticancer treatment

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Exclusion Criteria

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Addresses

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    • European Organisation for Research and Treatment of Cancer - EORTC
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    • Universitair Ziekenhuis Antwerpen
    • Jan B. Vermorken, MD, PhD 
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    • Universitair Ziekenhuis Antwerpen
    • Jan B. Vermorken, MD, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

  •   Clinical trial summary from the National Cancer Institute's PDQ® database
  •   Jansen J, Vermorken JB, Boote D, et al.: Cost-effectiveness analysis of the EORTC 24971 (TAX 323) trial comparing docetaxel plus cisplatin and 5-fluorouracil versus standard treatment (cisplatin and 5-fluorouracil) as induction chemotherapy followed by radiation therapy in locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN). [Abstract] J Clin Oncol 25 (Suppl 18): A-6090, 321s, 2007.
  •   van Herpen CM, Mauer ME, Mesia R, Degardin M, Jelic S, Coens C, Betka J, Bernier J, Remenar E, Stewart JS, Preiss JH, van den Weyngaert D, Bottomley A, Vermorken JB. Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). Br J Cancer. 2010 Sep 14; [Epub ahead of print]; 20842129
  •   Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704.; 17960012
  •   Bernier J, Coens C, Remenar E, et al.: Impact on quality of life (QoL) of the addition of docetaxel (T) to neoadjuvant cisplatin plus 5-fluorouracil treatment in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN): EORTC study 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5522, 285s, 2006.
  •   Remenar E, Van Herpen C, Lluch JG, et al.: A randomized phase III multicenter trial of neoadjuvant docetaxel plus cisplatin and 5-fluorouracil (TPF) versus neoadjuvant PF in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN). Final analysis of EORTC 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5516, 2006.
  •   Vermorken JB, Remenar E, Van Herpen C, et al.: Standard cisplatin/infusional 5-fluorouracil (PF) vs docetaxel (T) plus PF (TPF) as neoadjuvant chemotherapy for nonresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN): a phase III trial of the EORTC Head and Neck Cancer Group (EORTC #24971). [Abstract] J Clin Oncol 22 (Suppl 14): A-5508, 490s, 2004.
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.