search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


CROSS II.


- candidate number1697
- NTR NumberNTR487
- ISRCTNISRCTN80832026
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR16-sep-2005
- Secondary IDsEMC 03-209 (CKTO 2004-13) 
- Public TitleCROSS II.
- Scientific TitleNeoadjevant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinomas or squamous cell carcinomas of the esophagus.
- ACRONYMCROSS II
- hypothesisSurgery 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.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria18 < 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 criteriaT1N1, 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%.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-mrt-2004
- planned closingdate1-jan-2006
- Target number of participants350
- InterventionsPaclitaxel 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.
- Primary outcome1. 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 outcome1. To compare pathological responses;
2. Progression free survival;
3. Number of R0 resections;
4. Treatment toxicity;
5. Costs.
- 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, Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD16-sep-2005 - 29-okt-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl