Clinical trial · Interventional
Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma
NCT00060333CI-TRIAL-00026502completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (adjuvant radiation therapy)
- description
- 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.
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence
- timeFrame
- Within 2 years after treatment
- description
- The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (1)
- RESULTRule WG, Allred JB, Pockaj BA, Markovic SN, DiCaudo DJ, Erickson LA, Deming RL, Schild SE. Results of NCCTG N0275 (Alliance) - a phase II trial evaluating resection followed by adjuvant radiation therapy for patients with desmoplastic melanoma. Cancer Med. 2016 Aug;5(8):1890-6. doi: 10.1002/cam4.783. Epub 2016 Jul 1. PMID 27368067