Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 2:19 PM
Study NCT ID:
NCT04523818
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase Ib Trial of Preoperative Short-Course Chemoradiotherapy Followed by Chemotherapy for Resectable Gastric Adenocarcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
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 Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as capecitabine and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric adenocarcinoma.
SECONDARY OBJECTIVES:
I. To assess the rate of pathologic complete response (pathCR) in patients treated with preoperative short-course CXRT.
II. To assess the rate of perioperative complications after gastrectomy in patients treated with preoperative short-course CXRT.
III. To assess overall survival from the date of diagnosis in subjects treated with short course CXRT.
OUTLINE:
Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine orally (PO) twice daily (BID) or fluorouracil intravenously (IV) continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.
After the completion of study treatment, patients are followed up every 6 months for 5 years.
I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric adenocarcinoma.
SECONDARY OBJECTIVES:
I. To assess the rate of pathologic complete response (pathCR) in patients treated with preoperative short-course CXRT.
II. To assess the rate of perioperative complications after gastrectomy in patients treated with preoperative short-course CXRT.
III. To assess overall survival from the date of diagnosis in subjects treated with short course CXRT.
OUTLINE:
Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine orally (PO) twice daily (BID) or fluorouracil intravenously (IV) continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.
After the completion of study treatment, patients are followed up every 6 months for 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: