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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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 and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBeth-Israel Deaconess Medical Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGMassachusetts General Hospital at Newton Wellesley Hospital
Newton, Massachusetts, United States
RECRUITINGPathologic Complete Response Rate
All patients will undergo a full pathological review of their surgical specimen according to the AJCC Staging Classification, 6th. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen.
Time frame: 38 Weeks
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Toxicity associated with neoadjuvant FOLFOX/ nal-IRI and chemoradiation will be summarized by category and grade according to the CTCAE version 5.0 Acute and late toxicities will be scored using Common Toxicity Criteria (CTCAE) version 5. Toxicities will be noted and recorded in protocol-specific case reports from the time of first dose of protocol therapy until 5 years after the end of protocol therapy
Time frame: first dose of protocol therapy until 5 years after the end of protocol therapy
Clinical Response
The rate of objective clinical response to induction FOLFOX/ nal-IRI and chemoradiation will be reported as the proportion of eligible patients starting protocol therapy who achieve a complete or partial response as the best overall response
Time frame: 8 Weeks
Clinical Response
The rate of objective clinical response to induction FOLFOX/ nal-IRI and chemoradiation will be reported as the proportion of eligible patients starting protocol therapy who achieve a complete or partial response as the best overall response
Time frame: 16 Weeks
Clinical Response
The rate of objective clinical response to induction FOLFOX/ nal-IRI and chemoradiation will be reported as the proportion of eligible patients starting protocol therapy who achieve a complete or partial response as the best overall response
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Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks
Time frame: 25 Weeks
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the duration from the first date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause. PFS time will be censored at the date of last follow-up for patients still alive with no documentation of progressive disease. The PFS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Time frame: duration from the first date of protocol therapy to the earliest date of disease progression up 5 years
Overall Survival
Overall survival (OS) is defined as the duration from the first date of protocol therapy to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive. The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation
Time frame: first date of protocol therapy to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive up to 5 years