Back to results

Surgery or Chemoradiation for Esophageal Cancer

Primary Purpose

Esophageal Cancers

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Esophagectomy

Definitive chemoradiation

About this trial

This is an interventional treatment trial for Esophageal Cancers focused on measuring squamous cell carcinoma, esophagectomy, chemoradiotherapy, chemoradiation, Squamous cell carcinomas of the esophagus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Surgery, esophagectomy

Definitive chemoradiation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Overall survival and disease-free survival

Secondary Outcome Measures

Quality of life and function outcomes

Full Information

NCT ID

NCT01032967

First Posted

December 15, 2009

Last Updated

December 15, 2009

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01032967

Brief Title

Surgery or Chemoradiation for Esophageal Cancer

Official Title

Multicenter Prospective Randomized Trial Comparing Standard Esophagectomy With Chemoradiotherapy for Treatment of Squamous Esophageal Cancer: Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

July 2000 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancers

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery, esophagectomy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Definitive chemoradiation

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Esophagectomy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Definitive chemoradiation

Intervention Description

Primary Outcome Measure Information:

Title

Overall survival and disease-free survival

Time Frame

2 year and 5 year

Secondary Outcome Measure Information:

Title

Quality of life and function outcomes

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip W Chiu, FRCSEd (Gen)

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

22887465

Citation

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.

Results Reference

derived

PubMed Identifier

21233603

Citation

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.

Results Reference

derived

Learn more about this trial

Surgery or Chemoradiation for Esophageal Cancer

We'll reach out to this number within 24 hrs