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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01013623




Registration number
NCT01013623
Ethics application status
Date submitted
12/11/2009
Date registered
16/11/2009
Date last updated
26/09/2012

Titles & IDs
Public title
Stage IV Surgery Versus Best Medical Therapy
Scientific title
A Phase III, Randomized Trial of Surgical Resection With or Without BCG Versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma
Secondary ID [1] 0 0
3P01CA012582-35S1
Secondary ID [2] 0 0
MORD-STG4SURG-0409
Universal Trial Number (UTN)
Trial acronym
STG4SURG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IV Resectable Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Surgery
Treatment: Surgery - Surgery plus 2 adjuvant doses of BCG
Other interventions - best medical therapy

Active comparator: Best Medical Therapy - 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.

Active comparator: Surgery Alone - 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.

Active comparator: Surgery + BCG - The Surgery + BCG group will first have a complete resection (surgical removal) of all known disease, if possible. After recovery from surgery, two doses of BCG will be given two weeks apart. Each dose is given as 8 separate injections into the skin (called intradermal injections).


Treatment: Surgery: Surgery
surgical resection to remove all known disease

Treatment: Surgery: Surgery plus 2 adjuvant doses of BCG
Patients in the surgical resection + BCG arm will have an additional two visits to receive BCG. The first dose of BCG will be given no earlier than 4 weeks after surgery, and the second BCG dose will follow 2 weeks later. The actual doses are determined by the patient's pre-study tuberculin-reactivity status. Patients with a pre-study PPD induration of =10 mm will be given half the normal dose of BCG. Those with PPD induration of =20 mm will be given 25% of the normal dose.

Other interventions: best medical therapy
Patients randomized to the Best Medical Therapy arm will decide on a course of medical therapy based on what the patient's medical oncologists feels is best for the patient. Best systemic medical therapy may include clinical trials of new agents or standard non-protocol treatments. Patients who progress on the best medical treatment arm may switch to a different medical therapy or, if still appropriate, may receive surgery.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
3 interim analyses will be conducted when 75, 148, and 217 events (deaths) have occurred. The final analysis will be conducted when all 284 expected events have occurred.
Secondary outcome [1] 0 0
Time to progression of initial metastatic sites (progression-free survival)
Timepoint [1] 0 0
3 interim analyses will be conducted when 75, 148, and 217 primary events have occurred. The final analysis will be conducted when all 284 expected events have occurred.
Secondary outcome [2] 0 0
Melanoma-specific survival
Timepoint [2] 0 0
3 interim analyses will be conducted when 75, 148, and 217 recurrences/progressions have occurred. The final analysis will be conducted when all 284 expected events have occurred.
Secondary outcome [3] 0 0
Time to development of new metastatic sites.
Timepoint [3] 0 0
3 interim analyses will be conducted when 75, 148, and 217 primary events have occurred. The final analysis will be conducted when all 284 expected events have occurred.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Israel
State/province [10] 0 0
Tel-Aviv
Country [11] 0 0
Italy
State/province [11] 0 0
Naples
Country [12] 0 0
Netherlands
State/province [12] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Other
Name
Saint John's Cancer Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melanoma Research Alliance
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01013623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donald L. Morton, MD
Address 0 0
Saint John's Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01013623