Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060333
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2003-05-06
Brief Title:
Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy RT For Patients With Desmoplastic Melanoma
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 25 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
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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000301633 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2009-00641 | REGISTRY | None | None |