Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081289
Status:
COMPLETED
Last Update Posted:
2020-02-27
First Post:
2004-04-07
Brief Title:
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Randomized Phase II Trial Of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2020-02
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 work in 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 Chemoradiotherapy combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed Giving chemotherapy after surgery may kill any remaining tumor cells
PURPOSE This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer
PURPOSE This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer
Detailed Description:
OBJECTIVES
Evaluate the pathologic complete response rate in patients with locally advanced rectal cancer undergoing surgical resection treated with 2 different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy
Evaluate the time to treatment failure and patterns of failure in patients treated with these regimens
Evaluate the incidence of hematologic and non-hematologic grade 3-4 toxicity preoperatively postoperatively and overall in patients treated with these regimens
Evaluate the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to clinical stage of tumor T3 vs T4 Patients are randomized to 1 of 2 treatment arms
Quality of life is assessed at baseline within 1 week after completion of radiotherapy within 1 week after completion of adjuvant chemotherapy 12 months and then at 24 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Evaluate the pathologic complete response rate in patients with locally advanced rectal cancer undergoing surgical resection treated with 2 different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy
Evaluate the time to treatment failure and patterns of failure in patients treated with these regimens
Evaluate the incidence of hematologic and non-hematologic grade 3-4 toxicity preoperatively postoperatively and overall in patients treated with these regimens
Evaluate the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to clinical stage of tumor T3 vs T4 Patients are randomized to 1 of 2 treatment arms
Quality of life is assessed at baseline within 1 week after completion of radiotherapy within 1 week after completion of adjuvant chemotherapy 12 months and then at 24 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000350136 | None | None | None |