Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006231
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2000-09-11
Brief Title:
Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
Sponsor:
University of Glasgow
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2000-10
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known if radiation therapy is effective in preventing metastatic cancer following surgery
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma
Detailed Description:
OBJECTIVES
Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures such as chest drain insertion pleural aspiration pleural biopsy and thoracoscopy in patients with malignant mesothelioma
Determine whether the nodules that develop after radiotherapy are symptomatic in these patients
Compare the quality of life of patients treated with radiotherapy vs standard care alone
OUTLINE This is a randomized study
Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion pleural aspiration pleural biopsy or thoracoscopy and once the wounds have healed
Arm II Patients receive standard supportive care alone Quality of life is assessed at baseline and then at 1 2 4 6 9 and 12 months
Patients are followed at 1 2 4 6 9 and 12 months
PROJECTED ACCRUAL A total of 44 patients 22 per arm will be accrued for this study within 2 years
Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures such as chest drain insertion pleural aspiration pleural biopsy and thoracoscopy in patients with malignant mesothelioma
Determine whether the nodules that develop after radiotherapy are symptomatic in these patients
Compare the quality of life of patients treated with radiotherapy vs standard care alone
OUTLINE This is a randomized study
Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion pleural aspiration pleural biopsy or thoracoscopy and once the wounds have healed
Arm II Patients receive standard supportive care alone Quality of life is assessed at baseline and then at 1 2 4 6 9 and 12 months
Patients are followed at 1 2 4 6 9 and 12 months
PROJECTED ACCRUAL A total of 44 patients 22 per arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20033 | None | None | None |
| CRC-BOC-L52 | None | None | None |