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Dose escalation study for inoperable esophageal cancer patients.


- candidate number13123
- NTR NumberNTR3532
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jul-2012
- Secondary IDsNl38343.018.11 CCMO
- Public TitleDose escalation study for inoperable esophageal cancer patients.
- Scientific TitleA randomised trial of dose escalation in definitive chemoradiotherapy for patients with oesophageal cancer.
- ACRONYMart deco study
- hypothesisImprove local tumor control of inoperabel oesophageal tumors by escalation of the local radiation dose.
- Healt Condition(s) or Problem(s) studiedDefinitive chemoradiation, Inoperable oesophageal tumors, Dose escalation
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-aug-2012
- planned closingdate30-aug-2015
- Target number of participants260
- InterventionsAn 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
- Primary outcomeLocal 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.
- Secondary outcomeSurvival and grade 3-4 toxicity, measured at the same interval as local tumor control using an oesofagus toxicity form.
- TimepointsReport on adverse effect at 25% and 50% of required patients;
Final analyses at 18 months after entry of last patient.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.C.C.M. Hulshof
- CONTACT for SCIENTIFIC QUERIES M.C.C.M. Hulshof
- Sponsor/Initiator Academic Medical Center (AMC), Department of Radiotherapy, Arnhems Radiotherapeutic Institute (ARTI), Erasmus Medical Center, Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summaryA 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.
- Main changes (audit trail)
- RECORD10-jul-2012 - 11-aug-2012


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