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Head and Neck CancerPhase 3NCT00003888

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

A Phase 3 study testing cisplatin, docetaxel and fluorouracil in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 44 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
cisplatin, docetaxel and fluorouracil
Type of treatment
Surgery or procedure
How many people
359 participants
Where
44 sitesin 15 countries
Study dates
Apr 1999to Mar 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

44 sites in 15 countries.

44 sites in 15 countries

France7 sites

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • CHR Hotel Dieu

    Nantes, 44093

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

Other trials in France

Belgium5 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

  • Clinique Universitaire De Mont-Godinne

    Mont-Godinne Yvoir, 5530

Other trials in Belgium

Italy4 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Ospedale Santa Croce

    Cuneo, 12100

  • Istituti Fisioterapici Ospitalieri - Roma

    Rome, 00161

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Netherlands4 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

Other trials in Netherlands

Spain4 sites

  • Institut Catala d'Oncologia - Hospital Duran i Reynals

    Barcelona, 08907

  • Hospital General de Jerez

    Jerez de la Frontera, 11407

  • Universidad de Santiago - Hospital de Conxo

    Santiago de Compostela

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

United Kingdom4 sites

  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

  • Charing Cross Hospital

    London, England, W6 8RF

  • Middlesex Hospital- Meyerstein Institute

    London, England, WIT 3AA

  • Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

Other trials in United Kingdom

Austria3 sites

  • Landeskrankenhaus/Universitatskliniken Graz

    Graz, A-8036

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, A-1090

  • Kaiser Franz Josef Hospital

    Vienna, A-1100

Other trials in Austria

Germany3 sites

  • Martin Luther Universitaet

    Halle, DOH-0-6112

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • Mutterhaus der Borromaerinnen

    Trier, D-54219

Other trials in Germany

Hungary3 sites

  • National Institute of Oncology

    Budapest, 1125

  • Szent Margit Hospital

    Budapest, 3761

  • Borsod-Abauj-Zemplen County Hospital

    Miskolc, 3501

Other trials in Hungary

Switzerland2 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Ospedale San Giovanni

    Bellinzona, CH-6500

Other trials in Switzerland

Federal Republic of Yugoslavia1 site

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

Greece1 site

  • Ahepa University Hospital

    Thessaloniki, 54636

Other trials in Greece

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

Turkey (Türkiye)1 site

  • Istanbul University-Institute of Oncology

    Istanbul, 34390

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the detailed description

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.

Being tested
cisplatin, docetaxel, fluorouracil, radiation therapy
Keywords
stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2004 (estimated)
  2. Study startApr 1999
  3. Primary completionMar 2002
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003888
Sponsor's protocol ID
EORTC-24971
Other IDs
RP-56976-V-323
Status last verified
Jul 2015
First submitted
1 Nov 1999
Last updated
9 Jul 2018
Results posted
No

Publications

  • 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; EORTC Head and Neck Group. 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 Oct 12;103(8):1173-81. doi: 10.1038/sj.bjc.6605860. Epub 2010 Sep 14.

    PubMed 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. doi: 10.1056/NEJMoa071028.

    PubMed 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, docetaxel and fluorouracil in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 44 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in France, Belgium, Italy, Netherlands, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003888, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.

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