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Head and Neck CancerPhase 3NCT00002839

Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx

A Phase 3 study testing cisplatin, fluorouracil and conventional surgery in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 6 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
cisplatin, fluorouracil and conventional surgery
Type of treatment
Surgery or procedure
How many people
564 participants
Where
20 sitesin 6 countries
Study dates
Jul 1996to May 2004
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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven squamous cell carcinoma of the head and neck, including:
  • Stage III/IV cancer of the glottic or supraglottic larynx
  • Eligible T4 tumor defined as:
  • Bulging the valleculae
  • Bulging the hyothyroid membrane
  • Minimal thyroid cartilage invasion or suspicion of invasion on imaging
  • Stage II/III/IV cancer of the pyriform sinus or of the hypopharyngeal aspect of the aryepiglottic fold (with or without extension to postcricoid area)
  • No massive destruction of the thyroid cartilage
  • No continuity between primary tumor and a lymph node
  • Operable on first attempt (as assessed by head and neck surgeon) by classical total laryngectomy with or without partial pharyngectomy
  • No requirement for extended surgery (circumferential pharyngolaryngectomy)
  • No tumor suitable for partial (functional) surgery or requiring extended surgery that necessitates any kind of flap for closure
  • No N2c tumor unless no requirement for bilateral resection of internal jugular veins
  • Measurable or evaluable disease by panendoscopy and CT scan or MRI
  • Esophagoscopy required
  • Bronchofiberscopy recommended
  • No requirement for tracheotomy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • WHO 0-2

Hematopoietic:

  • WBC at least 4,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • No medical, psychological, or geographical condition that precludes study compliance
  • No serious nonmalignant systemic disease
  • No second malignancy except:
  • Carcinoma in situ of the cervix
  • Adequately treated nonmelanomatous skin cancer
  • No poor nutritional status unlikely to be restored to fair status within 3 weeks
  • No contraindication to CT scan or general anesthesia

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior anticancer biologic therapy

Chemotherapy

  • No prior anticancer chemotherapy

Endocrine therapy

  • No prior anticancer endocrine therapy

Radiotherapy

  • No prior anticancer radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No other prior anticancer therapy

Trial locations and contacts

20 sites in 6 countries.

20 sites in 6 countries

France10 sites

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21033

  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy3 sites

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milano (Milan), 20133

  • Ospedale Civile Monselice

    Monselice, Padova, 35043

  • Azienda Ospedaliera "Santa Maria Degli Angeli"

    Pordenone, 33170

Other trials in Italy

Netherlands3 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007 MB

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

Other trials in Netherlands

Belgium2 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

Other trials in Belgium

Israel1 site

  • Rambam Medical Center

    Haifa, 31096

Other trials in Israel

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS

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 chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.

Read the detailed description

OBJECTIVES:

  • Compare relapse-free survival and larynx preservation in patients with resectable hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and fluorouracil and radiotherapy.
  • Compare the health-related quality of life in patients treated with these regimens.
  • Compare the cost-effectiveness of these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by performance status, disease site, tumor stage, node stage, and center.

Patients are randomized to one of two treatment arms. Both groups may receive either conventional radiotherapy in single daily fractions, 5 days per week, for 7 weeks (option 1) or hyperfractionated radiotherapy in 2 daily fractions, 5 days per week, for 4-5 weeks (option 2), according to institutional policy.

  • Arm I: Patients receive cisplatin and fluorouracil every 3 weeks. Patients with a complete or partial response on day 42 receive 2 additional courses of chemotherapy followed by 7 weeks of radiotherapy beginning on day 80. After radiotherapy, patients with a complete remission enter follow-up; those with a partial remission proceed to surgery. Patients with stable or progressive disease proceed immediately to surgery with or without postoperative radiotherapy.
  • Arm II: Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses. Patients treated on radiotherapy option 1 are evaluated 2 months after completion of radiotherapy; those with a complete remission enter follow-up while all others proceed to surgery. Patients treated on option 2 are evaluated on day 42; those with a partial or complete response complete chemoradiotherapy and are then evaluated and treated like option 1 patients. Patients with stable or progressive disease on day 42 proceed to surgery with or without a third course of chemotherapy on week 7.

Patients are followed every 3 months for 3 years and at least every 6 months thereafter.

PROJECTED ACCRUAL: A total of 564 patients will be accrued for this study within 4 years.

Keywords
stage II squamous cell carcinoma of the hypopharynx, 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 posted27 Jan 2003 (estimated)
  2. Study startJul 1996
  3. Primary completionMay 2004

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
564 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002839
Sponsor's protocol ID
EORTC-24954
Status last verified
Jul 2018
First submitted
1 Nov 1999
Last updated
9 Jul 2018
Results posted
No

Publications

  • Lefebvre JL, Rolland F, Tesselaar M, Bardet E, Leemans CR, Geoffrois L, Hupperets P, Barzan L, de Raucourt D, Chevalier D, Licitra L, Lunghi F, Stupp R, Lacombe D, Bogaerts J, Horiot JC, Bernier J, Vermorken JB; EORTC Head and Neck Cancer Cooperative Group; EORTC Radiation Oncology Group. Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. J Natl Cancer Inst. 2009 Feb 4;101(3):142-52. doi: 10.1093/jnci/djn460. Epub 2009 Jan 27.

    PubMed 19176454

  • Lefebvre J, Horiot J, Rolland F, et al.: Phase III study on larynx preservation comparing induction chemotherapy and radiotherapy versus alternating chemoradiotherapy in resectable hypopharynx and larynx cancers. EORTC protocol 24954-22950. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA6016, 303s, 2007.

  • Bottomley A, Tridello G, Coens C, Rolland F, Tesselaar ME, Leemans CR, Hupperets P, Licitra L, Vermorken JB, Van Den Weyngaert D, Truc G, Barillot I, Lefebvre JL. An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer. 2014 Feb 1;120(3):390-8. doi: 10.1002/cncr.28392. Epub 2013 Oct 25.

    PubMed 24452673

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, fluorouracil and conventional surgery in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 6 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 20 sites in France, Italy, Netherlands, Belgium, Israel and 1 more country. 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 NCT00002839, which also lists 3 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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