Trials / Active Not Recruiting

Active Not RecruitingNCT04523818

Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

A Phase Ib Trial of Preoperative Short-Course Chemoradiotherapy Followed by Chemotherapy for Resectable Gastric Adenocarcinoma

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 25 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DRUG	Capecitabine	Given PO
DRUG	Fluorouracil	Given IV
RADIATION	Radiation Therapy	Undergo radiation therapy
PROCEDURE	Therapeutic Surgical Procedure	Undergo standard of care surgery

Timeline

Start date: 2020-08-11
Primary completion: 2028-12-31
Completion: 2028-12-31
First posted: 2020-08-24
Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04523818. Inclusion in this directory is not an endorsement.