Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Alliance for Clinical Trials in Oncology

Status and phase

Completed

Phase 2

Conditions

Recurrent Melanoma

Treatments

Radiation: radiation therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00060333

NCCTG-N0275

NCI-2009-00641 (Registry Identifier)

CDR0000301633 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.)