Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers

NCT05296005 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-02-07

No results posted yet for this study

Summary

This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, 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 x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Conditions

  • Clinical Stage I Gastric Cancer AJCC v8
  • Clinical Stage II Gastric Cancer AJCC v8
  • Clinical Stage IIA Gastric Cancer AJCC v8
  • Clinical Stage IIB Gastric Cancer AJCC v8
  • Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Gastric Adenocarcinoma
  • Pathologic Stage IB Gastric Cancer AJCC v8
  • Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage II Gastric Cancer AJCC v8
  • Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIA Gastric Cancer AJCC v8
  • Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Gastric Cancer AJCC v8
  • Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage III Gastric Cancer AJCC v8
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Gastric Cancer AJCC v8
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Gastric Cancer AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIC Gastric Cancer AJCC v8
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8

Interventions

DRUG

Capecitabine

Given PO

DRUG

Docetaxel

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin

Given IV

DRUG

Oxaliplatin

Given IV

RADIATION

Radiation Therapy

Undergo radiotherapy

PROCEDURE

Surgical Procedure

Undergo surgical resection

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Dayssy A Diaz Pardo, MD, MS · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

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Entities

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 NCT05296005 on ClinicalTrials.gov