Chemoradiation for irresectable (T4) oesophageal cancer: a phase II multicentre study
| ISRCTN | ISRCTN15521056 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15521056 |
| Secondary identifying numbers | EMC 03-092 (CKTO2004-02), NL370 (NTR410) |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr A van der Gaast
Scientific
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
| Study design | Phase II, non-randomised, non-controlled, multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Chemoradiation for irresectable (T4) oesophageal cancer: a phase II multicentre study |
| Study acronym | T4 |
| Study hypothesis | 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). |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Paclitaxel and carboplatin |
| Primary outcome measure | 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) 2. To evaluate toxicity of this chemotherapy regimen in this group of patients |
| Secondary outcome measures | 1. To determine Time To Progression (TTP) of the disease after treatment 2. To determine quality of life before, during and after treatment 3. To obtain insight in survival after treatment |
| Overall study start date | 30/10/2003 |
| Overall study end date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 43 |
| Total final enrolment | 54 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 30/10/2003 |
| Recruitment end date | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Government
Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The 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 |
| 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.
