Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Esophagogastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves the following standard of care interventions: FOLFOX (leucovorin calcium, 5-Fluorouracil, and oxaliplatin) Carboplatin Paclitaxel Radiation the...

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves the following standard of care interventions: FOLFOX (leucovorin calcium, 5-Fluorouracil, and oxaliplatin) Carboplatin Paclitaxel Radiation therapy This research study involves the following study intervention: - Liposomal irinotecan It is expected that about 40 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved liposomal irinotecan for your specific disease but it has been approved for other uses. The FDA has approved FOLFOX, carboplatin, and paclitaxel as treatment options for this disease.

Tracking Information

NCT #
NCT04656041
Collaborators
Ipsen
Investigators
Principal Investigator: Theodore S Hong, MD Massachusetts General Hospital