Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	EORTC-24954 NCT00002839

Objectives

1. 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.
2. Compare the health-related quality of life in patients treated with these regimens.
3. Compare the cost-effectiveness of these regimens.

Entry Criteria

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

  OR

• WHO 0-2

Hematopoietic:

• WBC at least 4,000/mm³

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

Expected Enrollment

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

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.

Lefebvre JL, Rolland F, Tesselaar M, et al.: Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. J Natl Cancer Inst 101 (3): 142-52, 2009.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jean-Louis Lefebvre, MD, Study coordinator		Ph: 33-20-295-531 Email: jl-lefebvre@o-lambret.fr

European Organization for Research and Treatment of Cancer

Jean-Claude Horiot, MD, PhD, Study coordinator		Ph: 33-3-8073-7501 Email: jchoriot@dijon.fnclcc.fr

Registry Information
Official Title		PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
Trial Start Date		1996-07-23
Registered in ClinicalTrials.gov		NCT00002839
Date Submitted to PDQ		1996-07-23
Information Last Verified		2002-12-06

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