Perhaps the greatest challenge to the clinician in the optimal management of stage IIIA disease is the lack of meaningful, definitive data from large randomized trials on which to base treatment decisions.
A large number of phase I and II trials are accruing involving locally advanced disease with newer chemotherapy agents, newer radiotherapy delivery techniques and fractionation schedules, and novel interventions such as vaccines and gene-based therapy. Fortunately, a number of large, multicenter phase III randomized trials are also ongoing, and on completion should provide results that serve as the basis for rationale treatment recommendations in the various clinical presentations of stage IIIA disease.
A. Adjuvant Therapy Phase III Randomized Trials
For fully resected minimal nodal disease patients (stage IIIA1-2), multiple randomized trials of postoperative chemotherapy are currently accruing, although recruitment is hampered by the reluctance of postsurgical patients to undergo chemotherapy and, particularly, to complete all planned cycles. Equally difficult is the reluctance of patients to be potentially randomized in phase III trials to the observation (no treatment) arm. canadian health care mall
National Cancer Institute of Canada Clinical Trials Group/ECOG (JBR-10): This study compares adjuvant vinorelbine and cisplatin to no chemotherapy (completed accrual and now closed).
FRE-IALT/EU-96010: A European-based worldwide study comparing adjuvant combination chemotherapy with cisplatin plus vindesine, vinblastine, vinorelbine, or etoposide to no chemotherapy in resected stage I, II, and IIIA disease.
CNR-NICO-01/EU-97010: A European study of adjuvant cisplatin and etoposide after completely resected stage I, II, and IIIA disease.
LLCG-BLT/EU-98003/MRC-BLT: A study comparing adjuvant cisplatin-based chemotherapy to no chemotherapy.