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Spots Global Cancer Trial Database for Stage IV Surgery Versus Best Medical Therapy

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We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Donald L. Morton, MD

Affiliation: Saint John's Cancer Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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