Folfox+Irinotecan+Chemort In Esophageal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04656041
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Esophagogastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX/ nal-IRI — DRUG
    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
  • Paclitaxel — DRUG
    Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
  • Carboplatin — DRUG
    Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
  • Proton Radiation Therapy — RADIATION
    Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks

Study Details

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

Key Dates

Start date
Jun 29, 2021
Status verified
Nov 2025
Primary completion
Apr 30, 2024
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOX/ nal-IRI
    Treatment will be administered on an outpatient basis. * FOLFOX with nal-IRI for eight two-week cycles (16 weeks total) * Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks * Surgery

Primary Outcome Measure

Pathologic Complete Response Rate [ Time Frame: 38 Weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth-Israel Deaconess Medical CenterBostonMassachusetts02215
Andrea Bullock, MD
[email protected]
(617) 667-2100
Andrea Bullock, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02115
Jennifer Wo, MD
[email protected]
617-726-6050
Jennifer Wo, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital at Newton Wellesley HospitalNewtonMassachusetts02462
Lawrence Blaszkowsky, MD
[email protected]
(617) 219-1230
Lawrence Blaszkowsky, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth-Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MAMassachusetts General Hospital at Newton Wellesley Hospital· Newton, MA

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