Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003799
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
1999-11-01
Brief Title:
Chemotherapy Radiation Therapy and Surgery in Treating Patients With Locally Advanced Rectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Preoperative Radiation Therapy With Concurrent Protracted Continuous Infusion 5-FU and Dose Escalating Oxaliplatin Followed by Surgery 5-FU and Leucovorin for Locally Advanced T3 and T4 Rectal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by surgery and additional chemotherapy in treating patients who have advanced nonmetastatic primary cancer of the rectum Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy radiation therapy and surgery may be an effective treatment for rectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I To identify maximally tolerated dose MTD and dose limiting toxicity DLT of oxaliplatin when combined preoperatively with concurrent radiation therapy XRT and fluorouracil 5-FU by PVI
II To evaluate the resection rate for T4 rectal cancers the pathologic CR rate for T3 and T4 rectal cancers and the expected versus actual type of resection APR vs LAR vs LARcoloanal anastomosis
III To make preliminary observations of patient survival and patterns of recurrence for this treatment combination
IV To evaluate anastomotic and sphincter function following pre-op combined modality therapy
OUTLINE This is a dose-escalation study of preoperative oxaliplatin
Patients receive fluorouracil IV continuously with concurrent radiotherapy for 55 weeks Patients also receive oxaliplatin IV over 2 hours on day 1 of weeks 1 3 and 5
Cohorts of 5 patients each receive escalating doses of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose-limiting toxicity Additional patients are treated at the MTD
Patients undergo surgery 6-8 weeks after completing preoperative chemotherapy and radiotherapy The surgical procedure is determined by the extent of the tumor before preoperative therapy The type of operative procedure may be abdominoperineal resection low anterior resection LAR or LARcoloanal anastomosis
Postoperative chemotherapy begins within 6 weeks after surgery comprising leucovorin calcium and fluorouracil IV on days 1-5 Treatment repeats every 21 days for 4 courses
Patients are followed every 3 months for 25 years every 6 months for 3 years then annually for 5 years
I To identify maximally tolerated dose MTD and dose limiting toxicity DLT of oxaliplatin when combined preoperatively with concurrent radiation therapy XRT and fluorouracil 5-FU by PVI
II To evaluate the resection rate for T4 rectal cancers the pathologic CR rate for T3 and T4 rectal cancers and the expected versus actual type of resection APR vs LAR vs LARcoloanal anastomosis
III To make preliminary observations of patient survival and patterns of recurrence for this treatment combination
IV To evaluate anastomotic and sphincter function following pre-op combined modality therapy
OUTLINE This is a dose-escalation study of preoperative oxaliplatin
Patients receive fluorouracil IV continuously with concurrent radiotherapy for 55 weeks Patients also receive oxaliplatin IV over 2 hours on day 1 of weeks 1 3 and 5
Cohorts of 5 patients each receive escalating doses of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose-limiting toxicity Additional patients are treated at the MTD
Patients undergo surgery 6-8 weeks after completing preoperative chemotherapy and radiotherapy The surgical procedure is determined by the extent of the tumor before preoperative therapy The type of operative procedure may be abdominoperineal resection low anterior resection LAR or LARcoloanal anastomosis
Postoperative chemotherapy begins within 6 weeks after surgery comprising leucovorin calcium and fluorouracil IV on days 1-5 Treatment repeats every 21 days for 4 courses
Patients are followed every 3 months for 25 years every 6 months for 3 years then annually for 5 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 |
|---|---|---|---|
| CDR0000066943 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E1297 | None | None | None |
| U10CA021115 | NIH | None | None |