NCT00022139|CompletedPhase 2

Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

NCCTG-N0044NCI-2012-02394CDR0000068789

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2003

StartedJan 2002

CompletionJan 2009

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jan 2002

Longer than P75 for phase_2

Geographic Reach

1 country

35 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

7 years study duration

First Submitted

Initial submission to the registry

August 10, 2001

Completed

5 months until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed

1.2 years until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed

3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed

Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

3.5 years

First QC Date

August 10, 2001

Last Update Submit

December 5, 2016

Conditions

Esophageal Cancer Gastric Cancer

Keywords

stage III gastric cancerstage II esophageal cancerstage III esophageal canceradenocarcinoma of the stomachsquamous cell carcinoma of the esophagusadenocarcinoma of the esophagus

Outcome Measures

Primary Outcomes (1)

Proportion of successes
Up to 4 years

Secondary Outcomes (8)

Toxicity-free rate
Up to 4 years
Clinical tumor response
Up to 4 years
Pathologic tumor response
Up to 4 years
Time to disease progression
Up to 4 years
Surgical outcome
Up to 4 years
+3 more secondary outcomes

Study Arms (1)

carboplatin + paclitaxel + fluorouracil + radiation + surgery

EXPERIMENTAL

Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery, patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2 weeks before surgery. Patients are followed every 3 months for 4 years.

Drug: carboplatinDrug: fluorouracilDrug: paclitaxelProcedure: conventional surgeryRadiation: radiation therapy