Chemoradiation for irresectable (T4) oesophageal cancer: a phase II multicentre study
| ISRCTN | ISRCTN15521056 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15521056 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | EMC 03-092 (CKTO2004-02), NL370 (NTR410) |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funder | Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands) |
- Submission date
- 27/02/2007
- Registration date
- 27/02/2007
- Last edited
- 26/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Erasmus Medical Centre
Department of Medical Oncology
P.O. Box 2040
Dr. Molewaterplein 40
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 463 4897 |
|---|---|
| a.vandergaast@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II, non-randomised, non-controlled, multicentre study |
| Secondary study design | Multi-centre |
| Scientific title | Chemoradiation for irresectable (T4) oesophageal cancer: a phase II multicentre study |
| Study acronym | T4 |
| Study objectives | Chemoradiation therapy for irresectable T4 oesophageal tumour improves response rate and survival compared to radiotherapy alone. |
| Ethics approval(s) | Approval received by the Medical Ethics Committee of Erasmus University Hospital on the 30th October 2003 (ref: EMC 03-092). |
| Health condition(s) or problem(s) studied | Oesophageal cancer |
| Intervention | Paclitaxel 50mg/m^2 and carboplatin Area Under the Curve (AUC) equals two on days one, eight, 15, 22, 29 and 36. A total of 50.4 Gy will be given in 28 fractions of 1.8 Gy, five fractions per week, starting on the first day of chemotherapy. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Paclitaxel and carboplatin |
| Primary outcome measure(s) |
1. To determine clinically complete biopsy proved response rate after a chemotherapy regime for patients with locally irresectable carcinoma of the oesophagus or gastric junction without distant metastases (stage T4 N0-1 MO) |
| Key secondary outcome measure(s) |
1. To determine Time To Progression (TTP) of the disease after treatment |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 43 |
| Total final enrolment | 54 |
| Key inclusion criteria | 1. T4 N0-1 M0 2. Tumour length less than 10 cm 3. Upper tumour border 2 cm of upper oesophageal sphincter 4. Tumour must not extend more than 4 cm into the stomach 5. World Health Organisation (WHO) grade zero to two 6. Adequate haematological, renal, hepatic and pulmonal function 7. Adequate caloric- and/or fluid intake |
| Key exclusion criteria | 1. Previous chemotherapy and or radiotherapy on mediastinum or upper abdomen 2. Myocardial Infarction (MI) within last six months 3. Ventricular arrhythmia or congestive heart failure 4. Second or third degree heart blocks 5. Pre-existing neurotoxicity more than grade one 6. Active infection |
| Date of first enrolment | 30/10/2003 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3000 CA
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 | 02/05/2006 | 26/08/2021 | Yes | No |
Editorial Notes
The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
