Phase 2
Completed N=20
Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
Recurrent Melanoma
Source: ClinicalTrials.gov NCT00060333 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence — 10 percentage of patients with LR
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence |
10 | — |
| SECONDARY Incidence of Regional and Systemic Metastases |
5 | — |
| SECONDARY Survival Time |
NA | — |
| SECONDARY Failure Time |
NA | — |
| SECONDARY Toxicity |
— | — |
| SECONDARY Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory |
11.8; 23.5; 29.4; 76.5; 64.7; 64.7 | — |
Eligibility 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 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.)
Data sourced from ClinicalTrials.gov (NCT00060333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.