A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up
Surgery
Neoplasms+9
+ Neoplasms by Histologic Type
+ Neoplasms by Site
Treatment Study
Summary
Study start date: November 1, 1996
Actual date on which the first participant was enrolled.OBJECTIVES: Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease. Determine the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with metastatic melanoma who can be resected to a disease-free state. OUTLINE: This is a multicenter study. All patients undergo gross total resection of all known disease. Patients whose disease cannot be completely resected or who have disease recurrence after surgery are removed from study. Patients found to have microscopic residual disease after surgery are considered completely resected. Resected tissue is submitted for analysis on protocol SWOG-9431. Patients may receive any adjuvant therapy (e.g., radiotherapy, interferon, and/or vaccines) deemed clinically appropriate by the treating physician. Patients are followed periodically for 5 years after study entry. PROJECTED ACCRUAL: A total of 100 eligible patients with completely surgically resected disease will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.77 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable Multiple resected sites or metastatic melanoma of unknown primary allowed provided all known disease can be grossly resected Recurrence in iliac lymph nodes after inguinal lymph dissection allowed No metastatic disease beyond the lesions planned for resection Confirmed by CT scan of chest, abdomen, pelvis, and CT or MRI of brain within 42 days of study Concurrent registration on protocol SWOG-9431 required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently disease free Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy in the adjuvant or metastatic setting allowed Chemotherapy: Prior chemotherapy in the adjuvant or metastatic setting allowed Endocrine therapy: Prior hormonal therapy in the adjuvant or metastatic setting allowed Radiotherapy: Prior radiotherapy in the adjuvant or metastatic setting allowed Surgery: See Disease Characteristics At least 14 days since prior surgery in the adjuvant or metastatic setting Other: Recovered from prior therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 124 locations
Alaska Regional Hospital Cancer Center
Anchorage, United StatesOpen Alaska Regional Hospital Cancer Center in Google MapsBanner Good Samaritan Medical Center
Phoenix, United StatesCCOP - Western Regional, Arizona
Phoenix, United StatesBanner Thunderbird Medical Center
Phoenix, United States