No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine clinically complete biopsy proved response rate after a chemotherapy regime for patients with locally irresectable carcinoma of the esophagus or gatric junction without distant metastases (stage T4N0-1MO).
To evaluate toxicity of this chemotherapy regimen in this group of patients.
Secondary outcome
To determine time to progression (TTP) of the disease after treatment. To determine quality of life before, during and after treatment. To obtain insight in survival after treatment.
Background summary
N/A
Study objective
Chemoradiation therapy for irresectable T4 esophageal tumor improves response rate and survival compared to radiotherapy alone.
Study design
N/A
Intervention
Paclitaxel 50mg/m2 and carboplatin AUC=2 on days 1, 8, 15, 22, 29 and 36.
A total of 50.4 Gy will be given in 28 fractions of 1.8Gy, 5 fractions per week, starting on the first day of chemotherapy.
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
Inclusion criteria
1. T4N0-1M0;
2. tumour length <10 cm;
3. upper tumour border 2 cm of upper esophageal sphincter;
4. tumor mus not extend more than 4 cm into the stomach;
5. WHO 0-2;
6. adequate haematological, renal, hepatic and pulmonal function, adequate caloric- and/or fluid intake.
Exclusion criteria
1. Previous chemotherapy and or radiotherapy on mediastinum or upper abdomen;
2. MI within last 6 months;
3. ventricular arrhythmia or congestive heart failure;
4. second or third degree heart blocks;
5. pre-existing neurotoxicity grade >1;
6. active infection.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL370 |
| NTR-old | NTR410 |
| Other | : EMC 03-092 (CKTO2004-02) |
| ISRCTN | ISRCTN15521056 |