MedTrace Logo

Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers

NCT03515941 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-10-12

Study results available
· View outcomes & findings →

Summary

This is an open-label, stratified, two arm design. All patients receive same initial standard preoperative chemotherapy and surgical resection. Patients will then be assigned to either standard postoperative chemotherapy if node negative at surgery or standard postoperative chemoradiation if node positive at surgery.

The primary objective of this study is to determine the feasibility of patients enrolling and receiving either postoperative chemoradiation or chemotherapy alone, based upon nodal status at surgery, following preoperative chemotherapy.

The secondary Objectives is to evaluate the rate of cancer recurrence in patients assigned to treatment based upon node status. To explore the potential correlation between changes in expression of a pre-specified panel of genes identified as relevant to gastrointestinal cancers in response to preoperative chemotherapy, using presence of nodal involvement at time of surgery as an indicator of response.

Conditions

Interventions

DRUG

Oxaliplatin

130 mg/m2 by IV (Arm 1)

DRUG

Capecitabine

625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

DRUG

Leucovorin

400 mg/m2 by IV (Arm 1 \& Arm 2)

DRUG

5-fluorouracil

400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

RADIATION

radiation

45 Gy in 1.8 Gy/fraction

Sponsors & Collaborators

  • Tannaz Armaghany

    lead OTHER

Principal Investigators

  • Tannaz Armaghany, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2020-03-17
Completion
2020-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03515941 on ClinicalTrials.gov