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Chemoradiation for irresectable (T4) esophageal cancer, a phase II multicenter study.


- candidate number1704
- NTR NumberNTR410
- ISRCTNISRCTN15521056
- Date ISRCTN created27-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR19-sep-2005
- Secondary IDsEMC 03-092 (CKTO2004-02) 
- Public TitleChemoradiation for irresectable (T4) esophageal cancer, a phase II multicenter study.
- Scientific TitleChemoradiation for irresectable (T4) esophageal cancer, a phase II multicenter study.
- ACRONYMT4
- hypothesisChemoradiation therapy for irresectable T4 esophageal tumor improves response rate and survival compared to radiotherapy alone.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 30-okt-2003
- planned closingdate1-jan-2007
- Target number of participants43
- InterventionsPaclitaxel 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.
- Primary outcomeTo 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 outcomeTo 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. A. Gaast, van der
- CONTACT for SCIENTIFIC QUERIESDr. A. Gaast, van der
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
CKTO
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-sep-2005 - 15-nov-2009


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