Condition category
Cancer
Date applied
23/08/2010
Date assigned
25/10/2010
Last edited
25/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jurjen Boonstra

ORCID ID

Contact details

Dr Molewaterplein 50
Rotterdam
3000 CA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Chemotherapy Followed by Surgery versus Surgery Alone in Patients with Oesophageal Squamous Cell Carcinoma: Long-term Results of a Randomised Controlled Trial

Acronym

Study hypothesis

Patients with oesophageal sqaumous cell carcinoma who receive preoperative chemotherapy have equal or better overall survival compared to patients who undergo surgery alone

Ethics approval

The study protocol was approved by the Ethics Committee of all participating institutions, and by the Review Board of the Netherlands Cancer Foundation

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Oesophageal squamous cell carcinoma

Intervention

Random assignment was stratified by age, gender, weight loss in the past four months and length of the tumor as measured by esophago-gastroscopy.
Patients assigned to preoperative chemotherapy (CS group) received neoadjuvant etoposide plus cisplatin. Cisplatin, at a dose of 80 mg/m2, was given intravenously over 4 hours on day one of each cycle preceded and followed by adequate hydration. Etoposide, at a dose of 100 mg/m2, was administered intravenously over 2 hours on day 1 (before cisplatin) and day 2, followed by etoposide 200 mg/m2 orally on days 3 and 5. This course was repeated in week 4. In case of clinical response, two subsequent courses of chemotherapy were administered in week 8 and 11. Surgery was performed between 4 and 6 weeks after the last course of chemotherapy.

Patients assigned to surgery alone (S group) recieved surgery as soon as possible.

Surgery protocol for both treatment groups:
For carcinomas of the upper half of the intra-thoracic esophagus a right-sided thoracotomy was performed. For carcinomas of the lower half of the intra-thoracic esophagus a transhiatal esophagectomy was preferred. The tumor and its adjacent lymph nodes were dissected en bloc. The left gastric artery was transected at its origin, with resection of local lymph nodes. The continuity of the digestive tract was restored by means of gastric tube reconstruction or colonic interposition with a cervical anastomosis.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Overall survival

Secondary outcome measures

Disease free survival

Overall trial start date

01/01/1989

Overall trial end date

01/01/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed squamous cell carcinoma of the intra-thoracic oesophagus
2. No evidence of distant metastases
3. Absence of unresectable local disease
4. Below 80 years of age
5. In adequate physical condition (Karnofsky score >70) to undergo surgery
6. Adequate hepatic, renal and bone marrow function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Synchronous cancer
2. Tumour localization in the cervical oesophagus (upper border, <18 cm from the incisor teeth)
3. Severe cardiovascular or pulmonary disease
Patients with previous malignancies were eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence; exceptions were made for adequately treated basal cell cancer of the skin or carcinoma in situ of the cervix.

Recruitment start date

01/01/1989

Recruitment end date

01/01/1996

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dr Molewaterplein 50
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 50
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1997 results in
Kok TC, van Lanschot JJB, Siersema PD, van Overhagen HV, Tilanus HW. Neoadjuvant chemotherapy in operable esophageal squamous cell cancer: final report of a phase III multicenter randomized controlled trial. Proc Am Soc Clin Oncol. 1997; 17:984.

Publication citations

Additional files

Editorial Notes