Chemotherapy Followed by Surgery versus Surgery Alone in Patients with Oesophageal Squamous Cell Carcinoma
| ISRCTN | ISRCTN54829649 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54829649 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/08/2010
- Registration date
- 25/10/2010
- Last edited
- 05/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jurjen Boonstra
Scientific
Scientific
Dr Molewaterplein 50
Rotterdam
3000 CA
Netherlands
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Chemotherapy Followed by Surgery versus Surgery Alone in Patients with Oesophageal Squamous Cell Carcinoma: Long-term Results of a Randomised Controlled Trial |
| Study objectives | 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(s) | The study protocol was approved by the Ethics Committee of all participating institutions, and by the Review Board of the Netherlands Cancer Foundation |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Overall survival |
| Secondary outcome measures | Disease free survival |
| Overall study start date | 01/01/1989 |
| Completion date | 01/01/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 160 |
| Total final enrolment | 169 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/01/1989 |
| Date of final enrolment | 01/01/1996 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dr Molewaterplein 50
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dr Molewaterplein 50
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/05/2011 | 05/08/2021 | Yes | No |
Editorial Notes
05/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. Details of abstract results have been added to the publication and dissemination plan.
