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Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinomas or squamous cell carcinomas of the esophagus
ISRCTN ISRCTN80832026
DOI 10.1186/ISRCTN80832026
ClinicalTrials.gov identifier
EudraCT number
Public title Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinomas or squamous cell carcinomas of the esophagus
Scientific title
Acronym CROSS II
Serial number at source NTR487; EMC 03-209 (CKTO 2004-13)
Study hypothesis 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.
Lay summary
Ethics approval Received from the local medical ethics committee
Study design Multicentre randomised active controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Esophageal cancer
Participants - inclusion criteria 1. Age >18, <75 years
2. Surgical resectable T2-3, N0-1, M0
3. Tumour length longitudinal <8 cm and radial <5 cm
4. No invasion tracheobronchial tree
5. Tumour must not extend more than 2 cm into the stomach
6. ECOG 0-2
Participants - exclusion criteria 1. T1N1
2. T1N0
3. Past or current history of malignancy other than entry diagnosis
4. Previous chemotherapy or radiotherapy
5. MI in last 6 months
6. Congestive heart failure or arrhythmia requiring medication
7. Neurotoxicity grade >1
8. Inadequate caloric and or fluid intake
9. Weight loss 10%
Anticipated start date 18/03/2004
Anticipated end date 01/01/2006
Status of trial Completed
Patient information material
Target number of participants 350
Interventions 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 preferably be performed within 6 weeks after completion of chemoradiation.
Primary outcome measure(s) 1. 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 outcome measure(s) 1. To compare pathological responses
2. Progression free survival
3. Number of R0 resections
4. Treatment toxicity
5. Costs
Sources of funding Dutch Cancer Society (Netherlands)
Trial website
Publications 2008 result in http://www.ncbi.nlm.nih.gov/pubmed/1903614
Contact name Dr  A.  Gaast, van der
  Address Erasmus Medical Center
Department of Medical Oncology
P.O. Box 5201
  City/town Rotterdam
  Zip/Postcode 3008 AE
  Country Netherlands
Sponsor Erasmus Medical Center, Department of Medical Oncology (Netherlands)
  Address P.O. Box 5201
  City/town Rotterdam
  Zip/Postcode 3008 AE
  Country Netherlands
Date applied 27/01/2006
Last edited 02/07/2009
Date ISRCTN assigned 27/01/2006
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