Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinomas or squamous cell carcinomas of the esophagus
| ISRCTN | ISRCTN80832026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80832026 |
| Protocol serial number | NTR487; EMC 03-209 (CKTO 2004-13) |
| Sponsor | Erasmus Medical Center, Department of Medical Oncology (Netherlands) |
| Funder | Dutch Cancer Society (Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 02/07/2009
- 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 A. Gaast, van der
Scientific
Scientific
Erasmus Medical Center
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CROSS II |
| Study objectives | Surgery is the standard therapy for esophageal cancer. However, 30% of the resections are irradical. It is thought that preceding chemoradiotherapy will improve the surgery results. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Esophageal cancer |
| Intervention | Paclitaxel 50 mg/m2 and carboplatin AUC = 2 on days 2, 8, 15, 22 and 29. Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Surgery (if randomised in this arm) will preferably be performed within 6 weeks after completion of chemoradiation. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Paclitaxel, carboplatin |
| Primary outcome measure(s) |
1. To compare median survival rates between patients treated for surgical resectable esophageal adenocarcinoma or squamous cell carcinoma |
| Key secondary outcome measure(s) |
1. To compare pathological responses |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 350 |
| Key inclusion criteria | 1. Age >18, <75 years 2. Surgical resectable T2-3, N0-1, M0 3. Tumour length longitudinal <8 cm and radial <5 cm 4. No invasion tracheobronchial tree 5. Tumour must not extend more than 2 cm into the stomach 6. ECOG 0-2 |
| Key exclusion criteria | 1. T1N1 2. T1N0 3. Past or current history of malignancy other than entry diagnosis 4. Previous chemotherapy or radiotherapy 5. MI in last 6 months 6. Congestive heart failure or arrhythmia requiring medication 7. Neurotoxicity grade >1 8. Inadequate caloric and or fluid intake 9. Weight loss 10% |
| Date of first enrolment | 18/03/2004 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | result | 01/06/1991 | Yes | No |
