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Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer - Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)

NCT ID: NCT00165061

Last Updated: 2005-09-14

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

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Brief Summary

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A multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer.

Detailed Description

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Cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year survival rate of 10-20%. Surgical resection with curative intent remains the most effective treatment for this disease. To improve the survival, a better treatment approach is in need to manage patients with oesophageal cancer. Unfortunately, the use of preoperative adjuvant chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with localized oesophageal cancer as proven in most randomized studies. However, the combination of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete pathological regression of the tumour as well as the response rate as shown in our preliminary results. In fact, treatment of squamous oesophageal cancer by primary chemo-irradiation without surgery is now feasible.

We propose to conduct a multi-center randomized trial to evaluate the efficacy and the patients' survival by comparing primary chemo-irradiation without surgery versus standard surgical resection as the treatment for squamous oesophageal cancer. Those patients with residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control the disease. Over a 3-year period, a total of 80 patients will be recruited from 4 different hospitals with 100 patients being randomized into each treatment arm. Treatment outcomes will be compared on an intention-to-treat analysis basis.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Esophagectomy

Intervention Type PROCEDURE

Chemoradiation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable

Exclusion Criteria

* distant metastasis to solid visceral organs
* local invasion into trachea, descending aorta or recurrent laryngeal nerve.
* patients \> 75 years
* serious premorbid condition
* poor physical status that compromised a thoracotomy
* compromised cardiac function
* creatinine clearance less than 50 ml/min were not eligible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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Philip WY Chiu, MBChB, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Angus CW Chan, MD

Role: STUDY_DIRECTOR

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Locations

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Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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CRE-9362

Identifier Type: -

Identifier Source: org_study_id