Completed

A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up

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What is being tested

Surgery

Procedure
Who is being recruted

Neoplasms+9

+ Neoplasms by Histologic Type

+ Neoplasms by Site

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1996
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 13, 2012
Sourced from a government-validated database.Claim as a partner

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.

NCT00002860
Principal SponsorSWOG Cancer Research Network
Last updated: January 13, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

77 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

NeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsMelanoma

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.
Treatment Groups
Study Objectives

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 Maps

Banner Good Samaritan Medical Center

Phoenix, United States

CCOP - Western Regional, Arizona

Phoenix, United States

Banner Thunderbird Medical Center

Phoenix, United States
Completed124 Study Centers