Phase 2
N=20
Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
Recurrent Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00060333 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence — 10 percentage of patients with LR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jun 2011
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 | — |
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.
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.