Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321685
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2006-05-02
Brief Title:
Bevacizumab Radiation Therapy and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Preoperative Radiation With Concurrent Capecitabine Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU Leucovorin Oxaliplatin FOLFOX and Bevacizumab in Patients With Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2019-03
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 studies how well giving bevacizumab radiation therapy and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Radiation therapy uses high-energy x-rays to kill tumor cells Drugs such as capecitabine may make tumor cells more sensitive to radiation therapy Drugs used in chemotherapy such as capecitabine oxaliplatin fluorouracil and leucovorin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor cells that remain after surgery
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the pathological complete response rate in patients with T3 and T4 rectal cancers when treated preoperatively with capecitabine oxaliplatin bevacizumab and concurrent radiotherapy XRT
II To evaluate the resection rate for T3 and T4 rectal cancers and the expected versus actual type of resection abdominoperinal resection APR vs low anterior resection LAR vs LARcoloanal anastomosis
III To make preliminary observations of patient survival and patterns of recurrence for this treatment combination
IV To gain additional experience regarding the toxicity and tolerability of this preoperative and postoperative regimen
OUTLINE
PREOPERATIVE CHEMORADIOTHERAPY Patients undergo radiotherapy total dose to the tumor bed was 5040 cGy once daily QD 5 days a week and receive capecitabine 825 mgm2 orally PO twice daily BID 5 days a week for 55 weeks Patients also receive oxaliplatin 50 mgm2 intravenously IV over 2 hours on days 1 8 15 22 and 29 and bevacizumab 5 mgkg IV over 30-90 minutes on days 1 15 and 29 during radiotherapy
SURGERY Approximately 6-8 weeks after completion of chemoradiotherapy patients undergo surgical resection Patients whose tumors are not completely resected or who have metastatic disease discontinue protocol therapy
POSTOPERATIVE CHEMOTHERAPY Approximately 4-12 weeks after surgery patients receive oxaliplatin IV over 2 hours leucovorin calcium 400 mgm2 IV over 2 hours and bevacizumab 5 mgkg IV over 30-90 minutes on day 1 Patients also receive fluorouracil 2400 mgm2 IV continuously over 46 hours beginning on day 1 Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity Patients then receive up to 3 additional courses of leucovorin calcium fluorouracil and bevacizumab
After completion of study treatment patients are followed up periodically for 10 years
I To evaluate the pathological complete response rate in patients with T3 and T4 rectal cancers when treated preoperatively with capecitabine oxaliplatin bevacizumab and concurrent radiotherapy XRT
II To evaluate the resection rate for T3 and T4 rectal cancers and the expected versus actual type of resection abdominoperinal resection APR vs low anterior resection LAR vs LARcoloanal anastomosis
III To make preliminary observations of patient survival and patterns of recurrence for this treatment combination
IV To gain additional experience regarding the toxicity and tolerability of this preoperative and postoperative regimen
OUTLINE
PREOPERATIVE CHEMORADIOTHERAPY Patients undergo radiotherapy total dose to the tumor bed was 5040 cGy once daily QD 5 days a week and receive capecitabine 825 mgm2 orally PO twice daily BID 5 days a week for 55 weeks Patients also receive oxaliplatin 50 mgm2 intravenously IV over 2 hours on days 1 8 15 22 and 29 and bevacizumab 5 mgkg IV over 30-90 minutes on days 1 15 and 29 during radiotherapy
SURGERY Approximately 6-8 weeks after completion of chemoradiotherapy patients undergo surgical resection Patients whose tumors are not completely resected or who have metastatic disease discontinue protocol therapy
POSTOPERATIVE CHEMOTHERAPY Approximately 4-12 weeks after surgery patients receive oxaliplatin IV over 2 hours leucovorin calcium 400 mgm2 IV over 2 hours and bevacizumab 5 mgkg IV over 30-90 minutes on day 1 Patients also receive fluorouracil 2400 mgm2 IV continuously over 46 hours beginning on day 1 Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity Patients then receive up to 3 additional courses of leucovorin calcium fluorouracil and bevacizumab
After completion of study treatment patients are followed up periodically for 10 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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2009-01081 | REGISTRY | None | None |
| CDR0000471148 | None | None | None |
| ECOG-E3204 | None | None | None |
| E3204 | OTHER | None | None |
| E3204 | OTHER | None | None |
| U10CA180820 | NIH | None | None |