Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Treatments: Capecitabine; Docetaxel; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• Evidence of distant metastatic disease

• Solitary functioning kidney within the potential radiation field

• Peripheral polyneuropathy > National Cancer Institute (NCI) grade II