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Adjuvant Radiation Therapy in...

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Last Updated: 2017-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2016-04-30

Brief Summary

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This phase II trial is studying how well adjuvant radiation therapy works in treating patients who have undergone surgery for desmoplastic melanoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any tumor cells remaining after surgery.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Assess the recurrence rates in patients with desmoplastic melanoma (DM) \>= 1 mm deep treated with adjuvant radiotherapy after surgical resection.

II. Assess recurrence rates in patients with locally recurrent DM treated with adjuvant radiotherapy after surgical resection.

SECONDARY OBJECTIVES:

I. Evaluate the impact of adjuvant radiation therapy after surgical resection on disease free and overall survival.

II. Evaluate the immediate and long-term morbidity of the addition of radiotherapy to surgery.

OUTLINE:

Within 8 weeks after surgical resection, patients undergo radiation therapy twice weekly over approximately 2.5 weeks for a total of 5 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

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Recurrent Melanoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (adjuvant radiation therapy)

Within 8 weeks after surgical resection, patients undergo radiation therapy twice weekly over approximately 2.5 weeks for a total of 5 fractions in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

radiation therapy

Intervention Type RADIATION

Interventions

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radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Pathologically proven DM \>= 1 mm in depth or locally recurrent DM; recurrent tumor is defined as a tumor found =\< 2 cm from the previous excision or within the surgical bed (which includes the extent of previous skin flaps)
* DM resected with pathologically negative margins; acceptable surgery includes standard wide local excision and Moh's surgery

* Tumors on the trunk proximal extremities need to have a \>= 2 cm negative margin; tumors located on the head and neck and distal extremities will have an attempt at 2 cm negative margins but due to location and subsequent concern regarding cosmesis a margin \< 2 cm will be acceptable if margin is negative
* Margins from tumors resected using the Moh's technique will be accepted if negative and best approximation of tumor width will be made
* Radiation therapy (RT) is to begin =\< 8 weeks after definitive surgical resection
* Adjuvant systemic therapy (immunotherapy or chemotherapy) must be postponed until irradiation is completed

Exclusion Criteria

* Previous irradiation to the same site
* Non-healing surgical wound
* Active infection at the surgical site
* Evidence of metastatic disease; local nodal disease is still eligible for the trial
* Life expectancy \< 1 year
* Melanoma with focally desmoplastic features, in which the desmoplastic melanoma is not the predominant histologic pattern of the tumor, will be excluded; non-desmoplastic neurotropic melanoma and non-desmoplastic spindle cell melanoma are also excluded
* Previous malignancy \< 5 years excluding basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ (with the exception of patients who have stage I breast cancer who were adequately treated with adjuvant therapy and are currently disease free, and patients with stage I or II prostate cancer treated with prostatectomy or radiotherapy and are biochemically free of disease \[for radical retropubic prostatectomy (RRP) prostate-specific antigen (PSA) \< 0.3 and for radiotherapy PSA \< 2.0 above the post treatment nadir\])
* Any of the following:

* Pregnant women
* Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, abstinence, etc.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara A. Pockaj, MD

Role: STUDY_CHAIR

Mayo Clinic Hospital

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status