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Surgery or Chemoradiation for Esophageal Cancer

NCT ID: NCT01032967

Last Updated: 2009-12-16

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2009-06-30

Brief Summary

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The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).

Detailed Description

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Conditions

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Esophageal Cancers

Keywords

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squamous cell carcinoma esophagectomy chemoradiotherapy chemoradiation Squamous cell carcinomas of the esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery, esophagectomy

The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy

Group Type ACTIVE_COMPARATOR

Esophagectomy

Intervention Type PROCEDURE

The patients will receive standard open esophagectomy with two-field lymphadenectomy

Definitive chemoradiation

3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.

Group Type ACTIVE_COMPARATOR

Definitive chemoradiation

Intervention Type RADIATION

3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.

Interventions

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Esophagectomy

The patients will receive standard open esophagectomy with two-field lymphadenectomy

Intervention Type PROCEDURE

Definitive chemoradiation

3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
* Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chinese University of Hong Kong

Principal Investigators

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Philip W Chiu, FRCSEd (Gen)

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

References

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Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.

Reference Type DERIVED
PMID: 22887465 (View on PubMed)

Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.

Reference Type DERIVED
PMID: 21233603 (View on PubMed)

Other Identifiers

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Surgery or CRT Ca Esophagus

Identifier Type: -

Identifier Source: org_study_id