Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003825
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
1999-11-01
Brief Title:
Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase III Study of Pentosanpolysulfate PPS in Treatment of GI Tract Sequelae of Radiotherapy
Status:
COMPLETED
Status Verified Date:
2013-08
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 Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum diarrhea or blood in stools caused by previous radiation therapy to the abdomen and pelvis
PURPOSE Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum diarrhea or blood in stools caused by previous radiation therapy to the abdomen and pelvis
Detailed Description:
OBJECTIVES I Evaluate the efficacy of pentosan polysulfate in patients with gastrointestinal tract sequelae after radiotherapy to the abdomen and pelvis II Determine the toxic effects of this drug in these patients III Determine the effect of this drug on symptoms and quality of life of these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral pentosan polysulfate three times a day for 2-6 months Arm II Patients receive oral placebo three times a day for 2-6 months Both arms Patients may receive retreatment for two months if symptoms return and last for at least 2 weeks Quality of life is assessed before treatment and at each follow up visit Patients are followed every 2 months for 6 months then every 3 months for 18 months then annually for 3 years
PROJECTED ACCRUAL A total of 174 patients will be accrued for this study within 3 years
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral pentosan polysulfate three times a day for 2-6 months Arm II Patients receive oral placebo three times a day for 2-6 months Both arms Patients may receive retreatment for two months if symptoms return and last for at least 2 weeks Quality of life is assessed before treatment and at each follow up visit Patients are followed every 2 months for 6 months then every 3 months for 18 months then annually for 3 years
PROJECTED ACCRUAL A total of 174 patients will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000066979 | None | None | None |