Improve local tumor control of inoperabel oesophageal tumors by escalation of the local radiation dose.
ID
Bron
Verkorte titel
Aandoening
inoperable oesophageal tumors
definitive chemoradiation
dose escalation
Ondersteuning
Arhems Radiotherapeutisch Institute, Arnhem
dept of oncology, Erasmusmc, Rotterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Local tumor control in the esophagus. Measured by anamnesis at 1, 2, 5, 8, 12, 18, 24, 36, 48 and 60 months, and by CT scans at 2, 8 and 18 months. Endoscopy and PET CT scan will be performed on indication.
Achtergrond van het onderzoek
A dose escalation study in patients with inoperable esophageal cancer referred for definitive chemoradiation. Randomisation between the standard dose of 50,4 Gy in fractions of 1.8 Gy and the experimental arm of 50,4 Gy/1.8 Gy combined with a concomittant boost of 11,2 Gy to the primary tumor, leading to a total tumordose of 61.6 Gy in daily fractions of 2.2 Gy. In both arms once weekly chemotherapy consisting of paclitaxel 50 mg/m and carboplatin (AUC = 2) will be administered as radiosenstitzer.
Doel van het onderzoek
Improve local tumor control of inoperabel oesophageal tumors by escalation of the local radiation dose.
Onderzoeksopzet
Report on adverse effect at 25% and 50% of required patients;
Final analyses at 18 months after entry of last patient.
Onderzoeksproduct en/of interventie
An increase of the radiation dose of on the primary tumor, from the standard dose of 50,4 Gy in daily fractions of 1.8 Gy, to 61.6 Gy in fractions of 2.2 Gy. The dose escalation will be administered with an conmittant boost technique, without increase of treatment time compared to the standard arm. The chemotherapy schedule is similar in both arms
Publiek
Meibergdreef 9
M.C.C.M. Hulshof
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664231
m.c.hulshof@amc.nl
Wetenschappelijk
Meibergdreef 9
M.C.C.M. Hulshof
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664231
m.c.hulshof@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. T1-4, N0-3,M0 medically or technically inoperable esophageal or junction tumors;
2. Histology proven;
3. WHO 0-2;
4. Tumor <- 10 cm;
5. Age > 18;
6. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Esophageal fistula;
2. Both pathological nodes at supraclavicular and truncus coeliacus level;
3. Junction tumors with supraclavicular nodes
histology other than squamous-, adeno- or large cell carcinoma;
4. Extensive CIS of the esophagus outside the planned RT field;
5. Esophageal stent;
6. Secondary malignancies other than bcc of the skin and DCIS of breast/cervix uteri;
7. Severe heart of neurologic disease.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3383 |
| NTR-old | NTR3532 |
| Ander register | CCMO : Nl38343.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |