NCT04656041

Folfox+Irinotecan+Chemort In Esophageal Cancer

A Phase II Study of Neoadjuvant NAPOX Followed by Chemoradiation With Paclitaxel and Carboplatin in Locally Advanced Esophagogastric Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this research study, is studying how Liposomal Irinotecan in combination with the standard of care interventions FOLFOX, carboplatin paclitaxel, and radiation therapy affect gastroesophageal junction or esophagogastric cancer This research study involves the following study intervention: \- Liposomal irinotecan

Detailed 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 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.

Conditions

• Gastroesophageal Junction Adenocarcinoma
• Esophagogastric Cancer

Interventions

Type	Name	Description
DRUG	FOLFOX/ nal-IRI	A cycle will be two weeks (14 days) long, with FOLFOX/ nal-IRI administered on days 1-3. The order of FOLFOX/ nal-IRI administration is as follows: * 1\) Liposomal Irinotecan free base via IV, predetermined dosage per protocol * 2\) Oxaliplatin via IV, predetermined dosage per protocol * 3\) Leucovorin via IV, predetermined dosage per protocol * 4\) 5-Fluorouracil via IV, predetermined dosage per protocol
DRUG	Paclitaxel	Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
DRUG	Carboplatin	Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
RADIATION	Proton Radiation Therapy	Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks

Timeline

• Start date: 2021-06-29
• Primary completion: 2024-04-30
• Completion: 2027-12-01
• First posted: 2020-12-07
• Last updated: 2025-11-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study