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

Alternate Title

Chemotherapy Compared With No Chemotherapy in Treating Patients With Resected Non-small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 70		CNR-ALPI EORTC-08952, EU-94043

Objectives

I.  Compare the overall and metastasis-free survival of patients with 
radically resected stage I/II/IIIA non-small cell lung cancer treated with 
adjuvant MVP (mitomycin/vindesine/cisplatin) vs. no adjuvant chemotherapy, 
with or without adjuvant thoracic radiotherapy.

II.  Assess the safety of adjuvant MVP.

Entry Criteria

Disease Characteristics:

Histologically documented non-small cell lung cancer
  No mixed small/non-small histology
  No multilobular involvement
  Unilobular bronchoalveolar carcinoma eligible

Pathologic stage I/II/IIIA (AJCC Staging System) with:
  Standard radical tumor resection and complete mediastinal lymph node
     resection or sampling
  Negative wide margins

Prior/Concurrent Therapy:

No prior chemotherapy, radiotherapy, or immunotherapy

Patient Characteristics:

Age:
  18 to 70
  Caution advised for ages 65-70, due to protocol toxicity

Performance status:
  ECOG 0 or 1

Hematopoietic:
  WBC at least 3,500/mm3
  Platelet count at least 120,000/mm3

Hepatic:
  Normal hepatic function

Renal:
  Creatinine no greater than 1.2 or 1.5 mg/dL (based on institutional limits)
        AND/OR
  Creatinine clearance at least 80 mL/min

Pulmonary:
  Postoperative FEV1 at least 1.2 liters

Other:
  No second malignancy except adequately treated:
     Basal cell skin cancer
     In situ carcinoma of the cervix

Expected Enrollment

1,240-1,840 patients will be enrolled over 4-5 years on this multicenter study.

Outline

Randomized study.  Prior to any randomization, the decision to administer 
radiotherapy on Regimen A is made by each participating institution for each 
patient.  If chosen, radiotherapy must be administered to patients on both 
arms (following completion of chemotherapy for those on Arm I).

The following acronyms are used:
  CDDP   Cisplatin, NSC-119875
  DAVA   Vindesine, NSC-245467
  MITO   Mitomycin, NSC-26980
  MVP    MITO/DAVA/CDDP

Arm I:  3-Drug Combination Chemotherapy.  MVP. 

Arm II:  Control.  No adjuvant chemotherapy.

Regimen A:  Radiotherapy.  Regional external-beam irradiation using 
megavoltage equipment (electrons reserved for the supraclavicular region).

Scagliotti GV, Fossati R, Torri V, et al.: Randomized study of adjuvant chemotherapy for completely resected stage I, II, or IIIA non-small-cell Lung cancer. J Natl Cancer Inst 95 (19): 1453-61, 2003.[PUBMED Abstract]

Tonato M: Final report of the Adjuvant Lung Project Italy (ALPI): an Italian/EORTC-LCG randomised trial of adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1157, 2002.

Clerici M: Randomized study of adjuvant chemotherapy for stage I-II-IIIA non-small cell lung cancer (NSCLC): report on the ALPI trial. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1141, 370, 1995.

Tonato M: A large scale randomized trial of adjuvant chemotherapy for Stage I-II-IIIA non-small cell lung cancer (NSCLC): Progress report on the ALPI trial. 5: A529, 144, 1995.

Trial Contact Information

Trial Lead Organizations

European Institute of Oncology

Maurizio Tonato, MD, Protocol chair(Contact information may not be current)		Ph: 39-075-578-3456 Email: mtonato@unipg.it

European Organization for Research and Treatment of Cancer

Giuseppe Giaccone, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 31-20-444-4321 Email: g.giaccone@vumc.nl