Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287196
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2006-02-03
Brief Title:
Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2009-09
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 trial seeks to establish the role of post-operative radiotherapy in patients who have had surgery for melanoma involving lymph nodes and who are at high risk of recurrence
Detailed Description:
This is a randomised phase III trial which is being performed on patients at high risk of local recurrence after having a lymphadenectomy for stage 3 melanoma The control arm is surgery alone with radiotherapy reserved for those who recur The study arm is surgery plus post-operative radiotherapy All 3 major node sites are eligible The radiation dose administered is 48Gy in 20 fractions It is likely to be the only study of its kind ever performed The target is 230 patients
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 |
|---|---|---|---|
| NHMRC 251732 | OTHER_GRANT | None | None |
| ANZMTG 0102 | OTHER | Austalian NewZealand Melanoma Trials Group | None |