NCT01196390|CompletedPhase 3Results

Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2011-02601CDR0000683717RTOG-1010U10CA180830U10CA180868U10CA021661

Study Type

interventional

Target

203

Locations

1 country

Sites

634

Timeline

RegisteredSep 2010

StartedFeb 2011

CompletionAug 2023

Brief Summary

This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

203

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Feb 2011

Longer than P75 for phase_3

Geographic Reach

1 country

634 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.5 years study duration

First Submitted

Initial submission to the registry

September 4, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed

5 months until next milestone

Study Start

First participant enrolled

February 14, 2011

Completed

8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

May 4, 2021

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed

Last Updated

February 18, 2026

Status Verified

January 1, 2026

Enrollment Period

8.9 years

First QC Date

September 4, 2010

Results QC Date

March 1, 2021

Last Update Submit

January 29, 2026

Conditions

Esophageal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Stage IB Esophageal Cancer AJCC v7 Stage IIA Esophageal Cancer AJCC v7 Stage IIB Esophageal Cancer AJCC v7 Stage IIIA Esophageal Cancer AJCC v7 Stage IIIB Esophageal Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

Disease-free Survival (DFS)
A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.
From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.

Secondary Outcomes (7)

Percentage of Participants With Pathologic Complete Response at Surgery
At the time of surgery, 5-8 weeks after completion of radiation therapy.
Overall Survival
From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
Frequency of Highest Grade Adverse Event Per Participant
From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
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
Quality-adjusted Survival
From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.
+2 more secondary outcomes

Other Outcomes (3)

Disease-free Survival (DFS) by Sex
From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.
Disease-free Survival (DFS) by Ethnicity
From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.
Disease-free Survival (DFS) by Race
From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.

Study Arms (2)

Arm I (radiotherapy, chemotherapy, trastuzumab)

EXPERIMENTAL

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.

Drug: CarboplatinOther: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Quality-of-Life AssessmentRadiation: Radiation TherapyProcedure: Therapeutic Conventional SurgeryBiological: Trastuzumab

Arm II (radiotherapy and chemotherapy)

EXPERIMENTAL

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.

Drug: CarboplatinOther: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Quality-of-Life AssessmentRadiation: Radiation TherapyProcedure: Therapeutic Conventional Surgery

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo