Condition category
Cancer
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
07/03/2007
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 van der Gaast

ORCID ID

Contact details

Erasmus Medical Centre
Department of Medical Oncology
P.O. Box 2040
Dr. Molewaterplein 40
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 4897
a.vandergaast@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMC 03-092 (CKTO2004-02)

Study information

Scientific title

Acronym

T4

Study hypothesis

Chemoradiation therapy for irresectable T4 oesophageal tumour improves response rate and survival compared to radiotherapy alone.

Ethics approval

Approval received by the Medical Ethics Committee of Erasmus University Hospital on the 30th October 2003 (ref: EMC 03-092).

Study design

Phase II, non-randomised, non-controlled, multicentre study

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oesophageal cancer

Intervention

Paclitaxel 50mg/m^2 and carboplatin Area Under the Curve (AUC) equals two on days one, eight, 15, 22, 29 and 36. A total of 50.4 Gy will be given in 28 fractions of 1.8 Gy, five fractions per week, starting on the first day of chemotherapy.

Intervention type

Drug

Phase

Phase II

Drug names

Paclitaxel and carboplatin

Primary outcome measures

1. To determine clinically complete biopsy proved response rate after a chemotherapy regime for patients with locally irresectable carcinoma of the oesophagus or gastric junction without distant metastases (stage T4 N0-1 MO)
2. To evaluate toxicity of this chemotherapy regimen in this group of patients

Secondary outcome measures

1. To determine Time To Progression (TTP) of the disease after treatment
2. To determine quality of life before, during and after treatment
3. To obtain insight in survival after treatment

Overall trial start date

30/10/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. T4 N0-1 M0
2. Tumour length less than 10 cm
3. Upper tumour border 2 cm of upper oesophageal sphincter
4. Tumour must not extend more than 4 cm into the stomach
5. World Health Organisation (WHO) grade zero to two
6. Adequate haematological, renal, hepatic and pulmonal function
7. Adequate caloric- and/or fluid intake

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

43

Participant exclusion criteria

1. Previous chemotherapy and or radiotherapy on mediastinum or upper abdomen
2. Myocardial Infarction (MI) within last six months
3. Ventricular arrhythmia or congestive heart failure
4. Second or third degree heart blocks
5. Pre-existing neurotoxicity more than grade one
6. Active infection

Recruitment start date

30/10/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Government

Funder name

Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The 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

Publication citations

Additional files

Editorial Notes