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Brief Title: Stage IV Surgery Versus Best Medical Therapy
Official Title: A Phase III, Randomized Trial of Surgical Resection With or Without BCG Versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma
Study ID: NCT01013623
Brief Summary: This study will establish the role of surgical versus nonsurgical approaches in patients whose melanoma has spread to distant sites. Results will help clinicians develop a standardized initial approach that prolongs survival and optimizes quality of life. Results also will indicate whether Bacillus Calmette-Guerin (BCG) postoperative immunotherapy significantly improves the outcome of patients treated with surgery.
Detailed Description: This study is designed to examine the impact of surgical resection versus medical therapy as initial treatment therapy for patients with Stage IV melanoma. Surgical resection is thought to be efficacious in highly selected patients with solitary metastases, but not in patients with multiple sites of metastases. Even in those with solitary metastases, there is considerable debate among major melanoma centers over whether undergoing initial systemic medical therapy prior to surgical resection should be preferred to initial surgical resection upon Stage IV diagnosis. According to Dr. Dan Coit, Co-leader of the Melanoma Disease Management Team at Memorial Sloan Kettering Cancer Institute in New York, a trial of initial medical therapy is their standard approach on the multidisciplinary melanoma service even for patients with solitary distant metastases (personal communication, 15 Dec 2009). Many who favor upfront medical therapy believe that delay before surgical resection may avoid unnecessary surgery by identifying patients who progress early due to the outgrowth of occult metastases at multiple sites, which may make the patient unresectable. This is a Phase III, randomized, international, multicenter study of metastasectomy with or without BCG versus best medical therapy as initial therapy in Stage IV melanoma. This study has three arms: surgical resection plus BCG as an immune adjuvant, surgical resection plus observation, and best medical therapy (BMT). Since no systemic medical therapy has been demonstrated to be superior to DTIC and multiple new therapies are being evaluated, the choice as to what constitutes best medical therapy will be determined by the individual investigator based on the standard of care for systemic medical therapy at that particular multicenter site. Best systemic medical therapy may include clinical trials of new agents or standard non-protocol treatments (e.g., DTIC or Temodar according to the standard of care at the multi-center site). Patients who progress on the best medical treatment arm may switch to a different medical therapy or, if appropriate, have surgical therapy; similarly, surgery patients may have additional surgical resection or receive medical therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC Davis Medical Center, Sacramento, California, United States
John Wayne Cancer Institute, Santa Monica, California, United States
Rush University, Chicago, Illinois, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Buffalo General Hospital, Buffalo, New York, United States
Wake Forest University, Winston-Salem, North Carolina, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Penn State Hershey Cancer Center, Hershey, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Geisinger Clinic, Wilkes-Barre, Pennsylvania, United States
Main Line Health System, Wynnewood, Pennsylvania, United States
Dallas Surgical Group, Dallas, Texas, United States
UT Southwestern Medical Center at Dallas, Dallas, Texas, United States
IHC Cancer Services Intermountain Healthcare, Murray, Utah, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Tel-Aviv Sourasky Medical Center, Tel-Aviv, , Israel
Istituto Nazionale dei Tumori Napoli, Naples, , Italy
Univesitair Medisch Centrum Groningen, Groningen, , Netherlands
Name: Donald L. Morton, MD
Affiliation: Saint John's Cancer Institute
Role: STUDY_CHAIR