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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
STEP 1 RANDOMIZATION: Patients must be age >= 18 years
STEP 1 RANDOMIZATION: Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

Study 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 Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival (DFS) (Step 2)
Pathologic complete response (Step I)
Secondary outcome measures
DFS
Incidence of adverse events
Overall survival
Other outcome measures
Percent change in mean volumetric apparent diffusion coefficient (ADC)

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
~6670
Biospecimen Collection
2004
Completed Phase 2
~1920
Ipilimumab
2014
Completed Phase 3
~2640
Positron Emission Tomography
2008
Completed Phase 2
~2260
Paclitaxel
2011
Completed Phase 4
~5380
Radiation Therapy
2017
Completed Phase 3
~7250
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,607 Previous Clinical Trials
40,913,706 Total Patients Enrolled
Jennifer R EadsPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new patients join this research project?

"Yes, this trial is seeking participants and was last updated on November 12th, 2022. The listing was originally posted on January 17th, 2019."

Answered by AI

Are there any other papers that mention Radiation Therapy?

"City of Hope Comprehensive Cancer Center first began studying Radiation Therapy in 1997. Since then, a total of 2020 clinical trials have completed with 1958 live studies. Many of these ongoing trials are based out of Carlisle, Pennsylvania."

Answered by AI

At how many different hospitals is this experiment being conducted?

"At the moment, this trial is looking for participants from 100 different sites. The locations include Carlisle, Matthews and Appleton; in addition to other cities that are closer to you to minimize travel time if selected for the study."

Answered by AI

For what sorts of medical conditions is Radiation Therapy commonly used?

"Radiation therapy is a cancer treatment that uses high-energy x-rays or particles to kill cancer cells. Radiation therapy can also be used to treat other conditions like unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."

Answered by AI
~76 spots leftby Jan 2026