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.
ID
Bron
Verkorte titel
Aandoening
Esophageal cancer.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. To compare median survival rates between patients treated for surgical resectable esophageal adenocarcinoma or squamous cell carcinoma;<br>
2. To compare quality of life before, during and after treatment.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
Wetenschappelijk
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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%.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL447 |
| NTR-old | NTR487 |
| Ander register | : EMC 03-209 (CKTO 2004-13) |
| ISRCTN | ISRCTN80832026 |