Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462501
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2007-04-18
Brief Title:
Combination Chemotherapy and Bevacizumab With or Without Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study of Neoadjuvant Chemotherapy With Selective Use of Radiation for Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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 Drugs used in chemotherapy such as 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 Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of rectal cancer by blocking blood flow to the tumor Radiation therapy uses high-energy x-rays to kill tumor cells Giving combination chemotherapy and bevacizumab together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without radiation therapy works in treating patients with locally advanced rectal cancer
PURPOSE This clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without radiation therapy works in treating patients with locally advanced rectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether neoadjuvant chemotherapy comprising oxaliplatin fluorouracil leucovorin calcium FOLFOX and bevacizumab can be substituted for pelvic radiotherapy without compromising R0 resection rates in patients with locally advanced rectal cancer
Secondary
Determine whether a 3-year local recurrence rate of 10 can be achieved in patients treated with this regimen
Determine the proportion of patients who achieve a complete pathologic response after treatment with this regimen
OUTLINE This is a non-randomized open-label pilot study
Neoadjuvant chemotherapy Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and bevacizumab IV over 10 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 1 3 5 and 7 Patients then receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 9 and 11 Treatment continues in the absence of disease progression or unacceptable toxicity
Within 3 weeks after completion of neoadjuvant chemotherapy patients undergo restaging evaluation Patients with no evidence of disease progression by endorectal ultrasound ERUS pelvic MRI and CT scan of the chestabdomen AND who remain candidates for R0 resection may proceed directly to surgical resection within 4-6 weeks after completion of neoadjuvant chemotherapy Patients with progressive disease who are not candidates for an R0 resection proceed to neoadjuvant chemoradiotherapy
Neoadjuvant chemoradiotherapy Patients undergo pelvic radiotherapy 5 days a week and receive concurrent fluorouracil IV continuously for 5½ weeks Within 4-7 weeks after completion of chemoradiotherapy patients undergo surgical resection
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Primary
Determine whether neoadjuvant chemotherapy comprising oxaliplatin fluorouracil leucovorin calcium FOLFOX and bevacizumab can be substituted for pelvic radiotherapy without compromising R0 resection rates in patients with locally advanced rectal cancer
Secondary
Determine whether a 3-year local recurrence rate of 10 can be achieved in patients treated with this regimen
Determine the proportion of patients who achieve a complete pathologic response after treatment with this regimen
OUTLINE This is a non-randomized open-label pilot study
Neoadjuvant chemotherapy Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and bevacizumab IV over 10 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 1 3 5 and 7 Patients then receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 9 and 11 Treatment continues in the absence of disease progression or unacceptable toxicity
Within 3 weeks after completion of neoadjuvant chemotherapy patients undergo restaging evaluation Patients with no evidence of disease progression by endorectal ultrasound ERUS pelvic MRI and CT scan of the chestabdomen AND who remain candidates for R0 resection may proceed directly to surgical resection within 4-6 weeks after completion of neoadjuvant chemotherapy Patients with progressive disease who are not candidates for an R0 resection proceed to neoadjuvant chemoradiotherapy
Neoadjuvant chemoradiotherapy Patients undergo pelvic radiotherapy 5 days a week and receive concurrent fluorouracil IV continuously for 5½ weeks Within 4-7 weeks after completion of chemoradiotherapy patients undergo surgical resection
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-07021 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |