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Platinum Complex

Combination Chemotherapy + Radiation for Esophageal Cancer

Phase 2

Recruiting

Led By Theodore S Hong, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤ 1

creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.

Must not have

History of allergic reaction(s) attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, or oxaliplatin.

Any prior chemotherapy, targeted/biologic therapy, or radiation for treatment of the participant's esophagogastric cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose of protocol therapy until 5 years after the end of protocol therapy

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying how well the study intervention works in combination with the standard of care interventions of FOLFOX, carboplatin paclitaxel, and radiation therapy in treating patients with gastroesophageal junction or esophagogastric cancer.

Who is the study for?

This trial is for adults over 18 with a specific type of esophageal or gastroesophageal junction cancer, confirmed by pathology. They must have an ECOG performance status ≤1 (which means they are fully active or restricted in physically strenuous activity but can do light work), a life expectancy over 3 months, and adequate organ/marrow function. Women who can bear children need a negative pregnancy test and agree to use contraception during the study.

What is being tested?

The trial tests Liposomal Irinotecan combined with standard treatments: FOLFOX (a chemotherapy regimen), carboplatin, paclitaxel, and radiation therapy on patients with gastroesophageal junction or esophagogastric cancer. The goal is to see how this combination affects their cancer.

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems; fatigue; hair loss; nerve damage causing numbness or tingling; allergic reactions; and liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all my pre-disease activities without restriction.

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My kidney function is within the required range.

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My cancer is in the advanced stage and affects the area where my stomach meets my esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain chemotherapy drugs like 5-fluorouracil, irinotecan, or oxaliplatin.

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I have received treatments like chemotherapy or radiation for my esophagogastric cancer.

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I had major surgery less than 4 weeks ago and haven't fully recovered.

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I am not pregnant or breastfeeding.

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I have a bleeding disorder that is not under control.

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I am allergic to 5-fluorouracil or have a DPD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose of protocol therapy until 5 years after the end of protocol therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose of protocol therapy until 5 years after the end of protocol therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose of protocol therapy until 5 years after the end of protocol therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic Complete Response Rate

Secondary study objectives

Clinical Response

Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

Overall Survival

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FOLFOX/ nal-IRIExperimental Treatment4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Radiation Therapy

2007

N/A

~30

Paclitaxel

FDA approved

Carboplatin

FDA approved