Status:
WITHDRAWN
Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Clinical Stage I Gastric Cancer AJCC v8
Clinical Stage II Gastric Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the feasibility of delivering tailored targeted neoadjuvant therapy with chemotherapy followed by chemoradiation and surgery in patients with gastroesophageal junct...
Eligibility Criteria
Inclusion
- Patients with histologically proven, cT2N0-T4aN3M0 (TNM 8th edition), gastric or Siewert II-III GEJ adenocarcinoma
- Evaluation with endoscopic ultrasound (EUS) and staging laparoscopy prior to enrollment is strongly recommended.
- Patient should be a candidate for neoadjuvant chemotherapy with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) or fluorouracil and oxaliplatin (FOLFOX).
- Patients should be \>= 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Patient should be eligible for surgical intervention
- T1 N0 disease (assessed by endoscopic ultrasound)
Exclusion
- Evidence of distant metastatic disease
- Solitary functioning kidney within the potential radiation field
- Peripheral polyneuropathy \> National Cancer Institute (NCI) grade II
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05296005
Start Date
December 31 2025
End Date
December 31 2025
Last Update
February 7 2025
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