No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To compare median survival rates between patients treated for surgical resectable esophageal adenocarcinoma or squamous cell carcinoma;
2. To compare quality of life before, during and after treatment.
Secondary outcome
1. To compare pathological responses;
2. Progression free survival;
3. Number of R0 resections;
4. Treatment toxicity;
5. Costs.
Background summary
N/A
Study objective
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.
Study design
N/A
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 be preferably be performed within 6 weeks after completion of chemoradiation.
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
18 < age < 75 year, surgical resectable T2-3, N0-1, M0, tumour length longitudinal <8cm and radial <5cm, no invasion tracheobronchial tree, tumour must not extend more than 2 cm into the stomach, ECOG 0-2.
Exclusion criteria
T1N1, T1N0, past or current history of malignancy other than entry diagnosis, previouw chemotherapy or radiotherapy, MI in last 6 months, congestive heart failure or arrhythmia requiring medication, neurotoxicity grade >1, inadequate caloric and or fluid intake, weight loss 10%.
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 | NL447 |
| NTR-old | NTR487 |
| Other | : EMC 03-209 (CKTO 2004-13) |
| ISRCTN | ISRCTN80832026 |