CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
radiation therapyradiation
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Pathologically proven desmoplastic melanoma >=1 mm in depth OR locally recurrent desmoplastic melanoma (tumor within 2 cm of previous excision or in surgical bed)
  • ✓Desmoplastic melanoma completely resected with pathologically negative margins
  • ✓Standard wide local excision or Moh's surgery acceptable; trunk/proximal extremities require >=2 cm negative margin, head/neck and distal extremities may have <2 cm if negative and required by cosmesis
  • ✓Radiation therapy to begin <=8 weeks after definitive surgical resection
Key exclusion· 7
  • ✕Previous irradiation to the same site
  • ✕Non-healing surgical wound
  • ✕Active infection at the surgical site
  • ✕Evidence of metastatic disease (local nodal disease is eligible)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00060333
NCT00060333Phase 2Completed
CompareCT.gov

Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma

Alliance for Clinical Trials in Oncology·interventional·Posted May 7, 2003·Updated Mar 17, 2017

In Brief

A Phase 2 clinical trial evaluating radiation therapy for Recurrent Melanoma. Completed, enrolled 20 participants across 39 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Melanoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2003
Enrollment StartJul 1, 2003
Primary CompletionJun 1, 2011
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 23.2 years ago

Interventions

radiation therapyradiation