Clinical trial · Interventional
Stage IV Surgery Versus Best Medical Therapy
A Phase III, Randomized Trial of Surgical Resection With or Without BCG Versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma
NCT01013623CI-TRIAL-00008153STG4SURGterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual, lack of continued funding.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Resectable Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| best medical therapy | Other | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| Surgery plus 2 adjuvant doses of BCG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Best Medical Therapy
- description
- The best medical therapy group will not initially undergo surgery, but will be treated with the therapy that medical oncologists or surgeons feel is best for the patient. This treatment may include standard or experimental therapies.
- interventionNames
- Other: best medical therapy
- type
- ACTIVE_COMPARATOR
- label
- Surgery Alone
- description
- The surgery alone group will undergo complete resection (surgical removal) of all known disease, if possible. After surgery, patients will be followed regularly and monitored for disease recurrence.
- interventionNames
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must provide informed written consent for participation. * At least 18 years of age * Have a minimum life expectancy (excluding melanoma) of 5 years. * All known disease must be surgically resectable in the opinion of a participating surgeon. * Must have a histologic diagnosis of Stage IV melanoma arising from a primary cutaneous site or visceral metastasis from an unknown primary site and be within 4 months of initial stage IV diagnosis. * Up to 3 visceral organs involved * Up to 6 lesions allowed * Must have ECOG performance status of 0 or 1. * Must be in good general health with no serious co-morbid illness. Good clinical judgment must be exercised in careful selection of patients who are candidates for surgical resection of distant metastases. * Laboratory values within 30 days of randomization: 1. WBC \>3,000/mm3 2. Lymphocytes \>800/mm3 3. Platelets \>100,000/mm3 4. Creatinine \<2.0 mg/dL 5. Bilirubin \<2.0 mg/dL 6. Alkaline phosphatase \< 2X upper limit of normal (ULN) 7. SGOT \< 2X ULN 8. SGPT \< 2X ULN 9. LDH \< 1.5X ULN Exclusion Criteria: * Unresectable metastatic disease or more than 4 months since stage IV diagnosis. * Brain or bone metastatic sites. * History of primary uveal or mucosal melanoma. * Another concomitant diagnosis that limits life expectancy to less than 5 years. * Chronic immunosuppression due to inherited, acquired or iatrogenic immune defect. This includes active HIV, hepatitis, or use of immunosuppressive medications as a component of anti-rejection therapy for organ transplant, as treatment for an autoimmune disease. * More than 3 involved visceral organ sites or more than 6 metastatic lesions. * Psychiatric disorder or organic brain syndrome that might preclude participation in the protocol. * Diagnosis of other malignancy in the past 5 years except adequately treated low grade malignancies such as basal cell carcinoma, cutaneous squamous cell carcinoma, carcinoma-in-situ of the cervix, or other neoplasm that will not limit life expectancy to less than 5 years. * Serious cardiac, gastrointestinal, hepatic or pulmonary disease that would make surgical resection high-risk. * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.