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

Alternate Title

Radiation Therapy With or Without Cisplatin in Treating 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 EORTC-22954

Objectives

I.  Compare relapse-free survival and larynx preservation in patients with 
resectable hypopharyngeal or laryngeal cancers treated with radiotherapy alone 
vs. radiotherapy with cisplatin.

II.  Compare the health-related quality of life in these patients and the cost 
effectiveness of treatment.

Entry Criteria

Disease Characteristics:

Biopsy-proven squamous cell carcinoma of the head and neck, including:
  Stage III/IV (T3-4 N0-N2b M0) 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 (T2-4 N0-N2b M0) 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 or MRI
  Esophagoscopy required
  Bronchofiberscopy recommended

No requirement for tracheotomy

This study conducted in parallel with protocol EORTC-24954

Prior/Concurrent Therapy:

No prior anticancer therapy

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG/WHO 0-2

Hematopoietic:
  WBC at least 4,000

Hepatic:
  Bilirubin no greater than 2.0 times normal

Renal:
  Creatinine no greater than 1.5 mg/dL (120 mmoles/L) OR
  Creatinine clearance at least 60 mL/min

Other:
  No medical, psychological, or geographical condition that precludes
     compliance with treatment or follow-up
  No serious nonmalignant systemic disease
  No second malignancy except:
     In situ carcinoma 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 or general anesthesia

Expected Enrollment

A total of 564 patients will be entered over 4 years in this multicenter study.

Outline

This is a randomized study.  Patients are stratified according to performance 
status, disease site, tumor stage, node stage, and participating institution.

Patients are randomized to one of two treatment arms.

Arm I:  Patients undergo radiotherapy alone.

Arm II:  Patients receive cisplatin on days 1, 22, and 43, plus radiotherapy.

Patients may receive higher doses of radiotherapy for 7 weeks, either once or 
twice a day (option 1) or lower doses of radiotherapy for 4-5 weeks, either 
once or twice a day (option 2).  Patients who undergo option 1, but do not 
attain complete response, proceed to surgery.  Patients who undergo option 2 
and attain complete or partial response continue to receive radiotherapy, but 
at the higher dose.  Those patients who experience no response or progressive 
disease proceed to surgery.

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

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

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

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