Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
02/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A. Gaast, van der

ORCID ID

Contact details

Erasmus Medical Center
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR487; EMC 03-209 (CKTO 2004-13)

Study information

Scientific title

Acronym

CROSS II

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.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Esophageal cancer

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Paclitaxel, carboplatin

Primary outcome measures

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 measures

1. To compare pathological responses
2. Progression free survival
3. Number of R0 resections
4. Treatment toxicity
5. Costs

Overall trial start date

18/03/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

350

Participant 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%

Recruitment start date

18/03/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3008 AE
Netherlands

Sponsor information

Organisation

Erasmus Medical Center, Department of Medical Oncology (Netherlands)

Sponsor details

P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Dutch Cancer Society (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 result in http://www.ncbi.nlm.nih.gov/pubmed/1903614

Publication citations

  1. Result

    Lehot JJ, Leone BJ, Foëx P, Effects of altered PaO2 and PaCO2 on left ventricular function and coronary hemodynamics in sheep., Anesth. Analg., 1991, 72, 6, 737-743.

Additional files

Editorial Notes