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Alkylating agents

Radiation Therapy for Esophageal Cancer

Phase 2 & 3

Waitlist Available

Led By Jennifer R Eads

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a combination of immunotherapy drugs, chemotherapy, and radiation therapy can shrink tumors more effectively than chemotherapy and radiation therapy alone in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.

Eligible Conditions

Esophageal Cancer
Esophageal cancer
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease-free survival (DFS) (Step 2)

Pathologic complete response (Step I)

Secondary study objectives

DFS

Incidence of adverse events

Overall survival

Other study objectives

Percent change in mean volumetric apparent diffusion coefficient (ADC)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (nivolumab, ipilimumab)Experimental Treatment4 Interventions

Patients receive nivolumab as in Arm C and receive ipilimumab IV over 90 minutes on day 1 of cycles 1 and 4 and day 15 of cycles 2 and 5. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.

Group II: Arm C (nivolumab)Experimental Treatment3 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.

Group III: Arm B (carboplatin, paclitaxel, radiation therapy, nivolumab)Experimental Treatment7 Interventions

Patients receive carboplatin, paclitaxel, and radiation therapy as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.

Group IV: Arm A (carboplatin, paclitaxel, radiation therapy)Experimental Treatment6 Interventions

Patients receive carboplatin IV and paclitaxel IV once weekly and undergo radiation therapy QD (Monday-Friday) beginning on day 1 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Carboplatin

2014

Completed Phase 3

~6120