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 measure
Overall survival
Secondary outcome measures
Disease free survival
Overall trial start date
01/01/1989
Overall trial end date
01/01/1996
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
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.