Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335816
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2006-06-08
Brief Title:
Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Timing of Rectal Cancer Response to Chemoradiation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 kill tumor cells Drugs used in chemotherapy such as fluorouracil oxaliplatin and leucovorin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Fluorouracil may also make tumor cells more sensitive to radiation therapy Leucovorin calcium may protect normal cells from the side effects of chemotherapy and it may help fluorouracil work better by making tumor cells more sensitive to the drug Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II trial is studying how well giving radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer
PURPOSE This phase II trial is studying how well giving radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer
Detailed Description:
OBJECTIVES
I To determine the rate of pathologic complete response to chemoradiation no evidence of residual tumor in the resected specimen of Stage II and Stage III rectal cancers that are staged preoperatively by endorectal ultrasound ERUS or magnetic resonance imaging MRI treated according to a standardized chemoradiation and surgery protocol and evaluated by a systematic pathologic exam of the surgical specimen
II To study the effect of different chemoradiation-to-surgery intervals on the rate of pathologic complete response on surgical difficulty and on postoperative complications
III To investigate the feasibility of using sensitive molecular assays to detect tumor cells in the tumor bed and regional lymph nodes of rectal cancer specimens with or without pathologic complete response to preoperative chemoradiation
OUTLINE
Patients are assigned to 1 of 4 treatment groups All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil intravenously IV continuously over 24 hours 7 days a week for 6 weeks
GROUP I closed to enrollment Patients undergo standard surgical resection after completion of chemoradiation therapy
GROUP II closed to enrollment Beginning 4 weeks after completion of chemoradiation therapy patients receive modified FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1-2 Treatment repeats every 14 days for 2 courses After the last week of post-radiation chemotherapy patients undergo standard surgical resection
GROUP III Beginning 4 weeks after completion of chemoradiation therapy patients receive modified FOLFOX-6 chemotherapy as in group II Treatment repeats every 14 days for 4 courses After the last week of post-radiation chemotherapy patients undergo standard surgical resection
GROUP IV Beginning 4 weeks after completion of chemoradiation therapy patients receive modified FOLFOX-6 chemotherapy as in group II Treatment repeats every 14 days for 6 courses After the last week of post- radiation chemotherapy patients undergo standard surgical resection
In all groups treatment continues in the absence of disease progression or unacceptable toxicity A
fter completion of study treatment patients are followed up for 5 years
I To determine the rate of pathologic complete response to chemoradiation no evidence of residual tumor in the resected specimen of Stage II and Stage III rectal cancers that are staged preoperatively by endorectal ultrasound ERUS or magnetic resonance imaging MRI treated according to a standardized chemoradiation and surgery protocol and evaluated by a systematic pathologic exam of the surgical specimen
II To study the effect of different chemoradiation-to-surgery intervals on the rate of pathologic complete response on surgical difficulty and on postoperative complications
III To investigate the feasibility of using sensitive molecular assays to detect tumor cells in the tumor bed and regional lymph nodes of rectal cancer specimens with or without pathologic complete response to preoperative chemoradiation
OUTLINE
Patients are assigned to 1 of 4 treatment groups All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil intravenously IV continuously over 24 hours 7 days a week for 6 weeks
GROUP I closed to enrollment Patients undergo standard surgical resection after completion of chemoradiation therapy
GROUP II closed to enrollment Beginning 4 weeks after completion of chemoradiation therapy patients receive modified FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1-2 Treatment repeats every 14 days for 2 courses After the last week of post-radiation chemotherapy patients undergo standard surgical resection
GROUP III Beginning 4 weeks after completion of chemoradiation therapy patients receive modified FOLFOX-6 chemotherapy as in group II Treatment repeats every 14 days for 4 courses After the last week of post-radiation chemotherapy patients undergo standard surgical resection
GROUP IV Beginning 4 weeks after completion of chemoradiation therapy patients receive modified FOLFOX-6 chemotherapy as in group II Treatment repeats every 14 days for 6 courses After the last week of post- radiation chemotherapy patients undergo standard surgical resection
In all groups treatment continues in the absence of disease progression or unacceptable toxicity A
fter completion of study treatment patients are followed up 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 |
|---|---|---|---|
| R01CA090559 | NIH | NCI PDQ | httpsreporternihgovquickSearchR01CA090559 |
| P30CA033572 | NIH | None | None |
| CHNMC-07182 | None | None | None |
| UCSF-H44287-23127-03 | None | None | None |
| UMN-2003UC036 | None | None | None |
| UCSF-03451 | None | None | None |
| CDR0000458059 | REGISTRY | None | None |