Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Phase 2

Completed

• Conditions: Esophageal Cancer
• Interventions: Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: fluorouracil; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

• Registration Number: NCT00069953
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells

PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.

Detailed Description

OBJECTIVES:

* Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction.

* Determine the overall and disease-free survival of patients treated with this regimen.

* Determine the treatment-related toxicity of this regimen in these patients.

* Determine the tolerance to surgical salvage in patients treated with this regimen.

* Determine the morbidity and mortality of surgical salvage in patients treated with this regimen.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity.

* Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96.

Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.

Patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-10-03
• Study First Submitted QC: 2003-10-06
• Study First Posted: 2003-10-07
• Primary Completion: 2007-03
• Results First Submitted: 2014-10-14
• Results First Submitted QC: 2014-10-14
• Results First Posted: 2014-10-20
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ChemoRT and selective surgery	paclitaxel	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	filgrastim	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	pegfilgrastim	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	conventional surgery	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	radiation therapy	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	cisplatin	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	fluorouracil	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.

Primary Outcome Measures

Name	Time	Method
Overall Survival (1-year Rate Reported)	From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.	One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).

Secondary Outcome Measures

Name	Time	Method
Frequency of Major (Grade 4) Acute Treatment-related Toxicities	From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).
Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection	Analysis occurs with the primary outcome measure.

Trial Locations

Locations (97)

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States

Saint Rose Hospital; 🇺🇸 Hayward, California, United States

Providence Holy Cross Cancer Center; 🇺🇸 Mission Hills, California, United States

CCOP - Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

Summit Medical Center; 🇺🇸 Oakland, California, United States

Valley Care Medical Center; 🇺🇸 Pleasanton, California, United States

J.C. Robinson, M.D. Regional Cancer Center; 🇺🇸 San Pablo, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Hospital of Saint Raphael; 🇺🇸 New Haven, Connecticut, United States

Baptist-South Miami Regional Cancer Program; 🇺🇸 Miami, Florida, United States

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