Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers
NCT05296005 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2025-02-07
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
-
Given PO
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
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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