Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070434
Status:
WITHDRAWN
Last Update Posted:
2012-06-07
First Post:
2003-10-03
Brief Title:
S0304 Induct Chemo Then Chemo-RT in Pts wLocally Advanced Adenocarcinoma of the Rectum
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients With Clinical T4 Rectal Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 irinotecan leucovorin fluorouracil and oxaliplatin 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 radiation therapy with chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum
PURPOSE This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum
Detailed Description:
OBJECTIVES
Determine the feasibility of obtaining a pre-treatment determination of intratumoral molecular markers TS DPD and ERCC-1 for use in selection of the appropriate regimen for induction cytotoxic combination chemotherapy in patients with cT3-4 rectal adenocarcinoma
Determine the response probability unconfirmed complete and partial in patients treated with targeted induction cytotoxic chemotherapy
Determine the toxicity of targeted induction cytotoxic chemotherapy and chemoradiotherapy in these patients
Determine the response probability in these patients treated with chemoradiotherapy
OUTLINE This is a multicenter study
Induction chemotherapy Patients are assigned to 1 of 3 treatment groups based on molecular analysis of the pretreatment tumor specimen
Group I lower likelihood of resistance to a fluorouracil-based regimen Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1
Group II higher likelihood of resistance to a fluorouracil-based regimen Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on day 1
Group III high likelihood of sensitivity to oxaliplatin and fluorouracil therapy Patients receive oxaliplatin IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1
Treatment in all groups repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are evaluated for response approximately 2 weeks after the completion of induction chemotherapy Patients with stable disease or better receive chemoradiotherapy
Chemoradiotherapy Beginning approximately 3 weeks after the completion of induction chemotherapy patients receive oral capecitabine twice daily continuously for 5 weeks and concurrent radiotherapy once daily 5 days a week for 5 weeks
After chemoradiotherapy patients may undergo attempted surgical resection at the discretion of the treating physician
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 10-65 patients will be accrued for this study
Determine the feasibility of obtaining a pre-treatment determination of intratumoral molecular markers TS DPD and ERCC-1 for use in selection of the appropriate regimen for induction cytotoxic combination chemotherapy in patients with cT3-4 rectal adenocarcinoma
Determine the response probability unconfirmed complete and partial in patients treated with targeted induction cytotoxic chemotherapy
Determine the toxicity of targeted induction cytotoxic chemotherapy and chemoradiotherapy in these patients
Determine the response probability in these patients treated with chemoradiotherapy
OUTLINE This is a multicenter study
Induction chemotherapy Patients are assigned to 1 of 3 treatment groups based on molecular analysis of the pretreatment tumor specimen
Group I lower likelihood of resistance to a fluorouracil-based regimen Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1
Group II higher likelihood of resistance to a fluorouracil-based regimen Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on day 1
Group III high likelihood of sensitivity to oxaliplatin and fluorouracil therapy Patients receive oxaliplatin IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1
Treatment in all groups repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are evaluated for response approximately 2 weeks after the completion of induction chemotherapy Patients with stable disease or better receive chemoradiotherapy
Chemoradiotherapy Beginning approximately 3 weeks after the completion of induction chemotherapy patients receive oral capecitabine twice daily continuously for 5 weeks and concurrent radiotherapy once daily 5 days a week for 5 weeks
After chemoradiotherapy patients may undergo attempted surgical resection at the discretion of the treating physician
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 10-65 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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0304 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |