Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/11/2015
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 - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICCG/8/91

Study information

Scientific title

Randomised phase II study of sequentially high dose Methotrexate and Fluorouracil combined with Epirubicin (FEMTX) versus FEMTX plus Cisplatin (FEMTX-P) in advanced gastric cancer

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Oesophagus, Stomach Cancer

Intervention

Patients are randomised to one of four treatment arms:
1. Arm A: Chemotherapy with FEMTX
2. Arm B: Chemotherapy with FEMTX plus Granulocyte Colony Stimulating Factor (G-CSF)
3. Arm C: Chemotherapy with FEMTX-P
4. Arm D: Chemotherapy with FEMTX-P plus G-CSF

Centres may choose to randomise to Arms A and Arm C only.
FEMTX: Chemotherapy with 5-flourouracil, high-dose methotrexate and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles.
FEMTX-P: Chemotherapy with 5-flourouracil, high-dose methotrexate, cisplatinum and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles.

Intervention type

Drug

Phase

Not Specified

Drug names

Methotrexate, fluorouracil, epirubicin and cisplatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

01/01/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged less than 70 years
2. Histologically confirmed locally advanced and/or metastatic gastric cancer
3. Measurable or evaluable disease
4. Karnofsky status 80-100
5. Adequate renal, hepatic and bone marrow function

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Previous chemotherapy or radiotherapy
2. Pleural or peritoneal effusions which cannot be adequately drained
3. Central Nervous System (CNS) metastases
4. History of previous or concomitant malignancy except squamous or basal cell carcinoma of the skin which has been effectively treated and carcinoma in situ of the cervix which has been treated operatively only
5. Other medical contraindications to treatment protocols

Recruitment start date

01/01/1996

Recruitment end date

01/01/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Pharmacia Ltd & Upjohn (UK)

Sponsor details

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101
info@adreco.co.uk

Sponsor type

Industry

Website

http://www.pharmacia.com

Funders

Funder type

Industry

Funder name

Pharmacia and Upjohn Ltd (UK)

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

30/11/2015: No publications found in PubMed.