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Alkylating agents

Trastuzumab for Esophageal Cancer

Phase 3

Waitlist Available

Led By Howard P Safran

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

Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start

Awards & highlights

Study Summary

This trial is testing how well radiation therapy, paclitaxel, and carboplatin work in treating patients with esophageal cancer, with or without trastuzumab.

Eligible Conditions

Esophageal Cancer
Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

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

Select...

If you have a tumor located at or above the carina (the area where the trachea splits into two bronchi), you must have a bronchoscopy to check for fistula (an abnormal connection between organs).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start 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)

Secondary outcome measures

Frequency of Highest Grade Adverse Event Per Participant

Molecular Correlates of Efficacy

Number of Participants With Any Cardiac Adverse Events Regardless of Attribution

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (radiotherapy and chemotherapy)Experimental Treatment6 Interventions

Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.

Group II: Arm I (radiotherapy, chemotherapy, trastuzumab)Experimental Treatment7 Interventions

Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57 and paclitaxel intravenously IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Beginning 21-56 days after surgery, patients receive trastuzumab IV over 30-90 minutes. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Trastuzumab

2014

Completed Phase 4

~5190

Carboplatin

2014

Completed Phase 3

~6670

Radiation Therapy

2017

Completed Phase 3

~7250

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,950 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,649 Total Patients Enrolled

Howard P SafranPrincipal InvestigatorNRG Oncology

Media Library

Esophageal Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01196390 — Phase 3

Frequently Asked Questions

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

Is this trial underway in more than one state?

"There are 100 enrollees for this trial at Kaiser Permanente-Richmond in Richmond, Oncology Hematology Care Inc-Anderson in Cincinnati, Saint Mary Mercy Hospital in Livonia, and 100 other hospitals around the country."

Answered by AI

Is Trastuzumab a new experimental drug?

"There are currently 1371 clinical trials underway that are studying Trastuzumab. Phase 3 trials, which are the 372 live studies, are nearing the final stages of testing. The large majority of these trials are based near Seattle, Washington but there are 74571 locations running trials for this treatment globally."

Answered by AI

What type of cancer does Trastuzumab target?

"Trastuzumab is the go-to medication for treating metastatic adenocarcinoma of the gastroesophageal junction. This medication can also be used to treat kaposi sarcoma, as well as aid in advance directives."

Answered by AI

Are there any available vacancies for patients in this study?

"No, this specific study is not recruiting patients at the moment, however there are 2361 other clinical trials with open recruitment at present. This study was first posted on December 30th, 2010 and was last updated on August 30th, 2022."

Answered by AI