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

Alternate Title

Chemoprevention of Second Cancers in Patients Previously Treated for Cancer of the Throat or Mouth or Non-Small Cell Lung Cancer

Basic Trial Information

Objectives

I.  Compare the frequency and time to occurrence of second primary tumors in 
this patient population after random assignment to treatment during follow-up 
with retinol palmitate vs. N-acetylcysteine vs. both drugs vs. no drug.

Entry Criteria

Disease Characteristics:

Curatively treated tumor of the upper aerodigestive tract of 1
of the following kinds:
  Carcinoma in situ of the larynx

  Invasive squamous cell carcinoma of the larynx Stage
  T1-3, N0-1, M0

  Invasive squamous cell carcinoma of the oral cavity Stage
  T1-2, N0-1, M0

  Completely resected nonsmall cell lung cancer stages pT1-2,
  N0-1, M0 and T3, N0, M0.

No synchronous (i.e., multiple) tumors

Adjuvant treatment or follow-up on other protocols allowed
  Concurrent treatment noted and patients stratified separately

  Treatment of index tumor is entirely at the discretion of the
  responsible physician and is not affected by enrollment on
  this protocol

Randomization to take place any time following surgery or
completion of locoregional radiotherapy for the index tumor

Prior/Concurrent Therapy:

Biologic therapy:
  Prior therapy allowed

Chemotherapy:
  Prior therapy allowed

Endocrine therapy:
  Prior therapy allowed

Radiotherapy:
  Prior radiotherapy allowed

Surgery:
  Prior surgery allowed

Other:
  At least 1 year since treatment for peptic ulcer

Patient Characteristics:

Age:
  75 and under

Performance status:
  WHO 0-2

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin no more than 1.0 mg/dl (30 micromoles/liter)
  SGOT and SGPT no more than 100 micromoles/liter
  No severe hypertriglyceridemia
  No severe hypercholesterolemia

Renal:
  Creatinine no more than 1.7 mg/dl (15 micromoles/liter)
  No severe hypercalcemia

Cardiac:
  No severe hypertension

Other:
  No documented hypersensitivity to retinol palmitate or N-
     acetylcysteine
  No severe diabetes
  No peptic ulcer within 1 year
  No psychosis
  No glaucoma
  No prior malignancy except:
     Basal cell skin cancer
     Cone-biopsied in situ carcinoma of the cervix
  No pregnant or nursing women
  Adequate contraception required of fertile women

Expected Enrollment

2,600 patients will be entered.

Outline

Randomized study.

Arm I:  2-Drug Chemoprevention.  Retinol palmitate, Vitamin A, VIT-A, 
NSC-122759; N-Acetylcysteine, NAC, NSC-111180.

Arm II:  Single-Agent Chemoprevention.  VIT-A.

Arm III:  Single-Agent Chemoprevention.  NAC.

Arm IV:  No further treatment.

De Vries N, Van Zandwijk N, Pastorino U: The EUROSCAN study: a progress report. Am J Otolaryngol 14 (1): 62-6, 1993 Jan-Feb.[PUBMED Abstract]

van Zandwijk N: N-acetylcysteine for lung cancer prevention. Chest 107 (5): 1437-41, 1995.[PUBMED Abstract]

van Zandwijk N: N-acetylcysteine (NAC) and glutathione (GSH): antioxidant and chemopreventive properties, with special reference to lung cancer. J Cell Biochem Suppl 22: 24-32, 1995.[PUBMED Abstract]

van Zandwijk N, Pastorino U, de Vries N: Chemoprevention of cancer. Eur Respir J 6 (3): 322-4, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

N. Zandwyk, MD, PhD, Protocol chair		Ph: 31-20-512-2958 Email: n.v.zandwijk@nki.nl

European Organization for Research and Treatment of Cancer

Nico De Vries, MD, PhD, Protocol chair		Ph: 31-20-510-8894 Email: ndevries@knmg.nl

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