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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 75 EORTC-24891

Objectives

I.  Evaluate the feasibility of conservation of the larynx in patients with 
operable squamous cell carcinoma of the hypopharynx treated with 
cisplatin/5-fluorouracil (CDDP/5-FU) as induction followed by definitive 
radiotherapy.

II.  Evaluate the duration of preservation of laryngeal function in these 
patients.

III.  Compare the overall 3-year survival of patients with operable squamous 
cell carcinoma of the hypopharynx randomly assigned to treatment with 
CDDP/5-FU followed by definitive irradiation vs. standard surgery plus 
postoperative radiotherapy.

Entry Criteria

Disease Characteristics:

Histologically proven squamous cell carcinoma of the pyriform
sinus and/or lateral wall of the epilarynx (i.e., the medial
wall of the pyriform sinus) with or without extension towards
the post-cricoid area

  No tumors extending to the tonsillar fossa, the posterior
  wall of the pharynx, or the esophageal junction

  No tumors of the posterior wall of the pharynx or the
  postcricoid area

TNM Stage T2-4, N0-2b and operable N3, M0 required:

  Tumor operable at initial surgery and suitable for classical
  total pharyngolaryngectomy required, i.e.:

     No possible requirement for functional surgery

     No requirement for extended surgery requiring a plastic
     procedure for pharyngeal closure

Measurable and/or evaluable disease documented by endoscopy
and, if possible, CT, required

Prior/Concurrent Therapy:

No prior therapy

Patient Characteristics:

Age:
  18 to 75

Performance status:
  WHO 0-2

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000

Hepatic:
  Not specified

Renal:
  Creatinine no greater than 1.5 mg/dl
  Creatinine clearance at least 60 ml/min

Other:
  Nutritional status adequate (at a minimum convertible to fair
     nutritional status within 3 weeks)
  No contraindication to surgery or fluid challenge
  No serious nonmalignant disease
  No overt psychosis or marked senility
  No history of second malignancy except:
     In situ cervical cancer
     Adequately treated nonmelanomatous cell skin cancer

Expected Enrollment

It is estimated that the required 425 patients will be accrued in about 4.25 
years.

Outline

Randomized study.

Arm I:  Surgery plus Postoperative Radiotherapy.  Total laryngectomy with 
partial pharyngectomy and radical neck dissection; plus postoperative 
irradiation of the primary site and the neck bilaterally using Co60 equipment, 
linear accelerators, or electrons.

Arm II:  2-Drug Combination Chemotherapy followed by Definitive Radiotherapy 
or by Surgery and Postoperative Radiotherapy.  Fluorouracil, 5-FU, NSC-19893; 
Cisplatin, CDDP, NSC-119875; followed by definitive irradiation of the primary 
site and the neck bilaterally (for complete responders) or by 
laryngectomy/partial pharyngectomy and primary site/neck irradiation as in Arm 
I (for nonresponders).

Lefebvre JL, Chevalier D, Luboinski B, et al.: Is laryngeal preservation (LP) with induction chemotherapy (ICT) safe in the treatment of hypopharyngeal SCC? Final results of the phase III EORTC 24891 trial . [Abstract] J Clin Oncol 22 (Suppl 14): A-5531, 495, 2004.

Lefebvre JL, Sahmoud T: Larynx preservation in hypopharynx squamous cell carcinoma: preliminary results of a randomized study (EORTC 24891). [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-912, 283, 1994.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

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

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