Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.

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Detailed Description

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Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.

Conditions

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Esophageal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neoadjuvant Treatment

Preoperative chemotherapy/radiotherapy treatment

Group Type OTHER

Preoperative treatment of chemotherapy and radiation

Intervention Type OTHER

Cisplatin + 5FU with concurrent radiation followed by surgery

Adjuvant Treatment

Postoperative chemotherapy/radiotherapy treatment

Group Type EXPERIMENTAL

Postoperative treatment of chemotherapy and radiation

Intervention Type OTHER

Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation

Interventions

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Preoperative treatment of chemotherapy and radiation

Cisplatin + 5FU with concurrent radiation followed by surgery

Intervention Type OTHER

Postoperative treatment of chemotherapy and radiation

Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20 cm from the incisors) or gastroesophageal junction are included.
* No distant metastases (M0).
* Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon.
* Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
* Resectable mediastinal nodes are eligible.
* No prior chemotherapy for this malignancy.
* No prior radiotherapy that would overlap the field(s) treated in this study.
* Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
* Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

Exclusion Criteria

* Cancers of the cervical esophagus (\< 20 cm are excluded).
* Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
* Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
* Patients with biopsy proven metastatic celiac nodes are ineligible.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No