Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
21/11/2012
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 D Cunningham

ORCID ID

Contact details

GI and Lymphoma Units
Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RMH E/C 1040

Study information

Scientific title

Acronym

Study hypothesis

Added 16/04/2009:
To compare protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin C (MMC) in patients with advanced oesophago-gastric cancer.

As of 05/08/09 this trial was updated. All updates can be found under the relevant field with the above update date.

Ethics approval

Added 16/04/2009: The study was approved by the Local Research and Ethics Committee at each of the five participating centres.

Study design

Multicentre 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

Advanced oesophago-gastric cancer

Intervention

Two arms:
1. Protracted venous infusion (PVI) 5FU 300 mg/m^2/day over 24 weeks
2. PVI 5FU 300 mg/m^2/day over 24 weeks and mitomycin-C 7 mg/m^2 (total dose no more than 56 mg) four courses over 24 weeks

Intervention type

Drug

Phase

Phase III

Drug names

5-fluorouracil (5FU), mitomycin-C

Primary outcome measures

Added 16/04/2009:
1. Tumour response, assessed by computed tomography (CT) scan before chemotherapy, 6-weekly during chemotherapy and 3-monthly thereafter until death or disease progression
2. Survival
3. Toxicity, evaluated on a weekly basis and graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC)
4. Quality of life, assessed using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires before randomisation and every 12 weeks thereafter

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/1994

Overall trial end date

31/03/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological evidence of metastatic carcinoma of the oesophagus or stomach
2. Histological evidence of locally advanced oesophageal or gastric carcinoma, not amenable to surgery or radiotherapy and for whom high dose chemotherapy or more intensive chemotherapy is not appropriate, normally around the age of 60

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

254

Participant exclusion criteria

1. Intra-cerebral metastases
2. History of other malignancy (apart from adequately treated non-melanotic skin cancer or carcinoma in situ of the uterine cervix)
3. Uncontrolled angina pectoris or clinically significant cardiac dysrhythmias
4. Pregnancy
5. Any psychological condition precluding informed consent

Recruitment start date

01/07/1994

Recruitment end date

31/03/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

GI and Lymphoma Units
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Royal Marsden NHS Foundation Trust (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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12377644

Publication citations

  1. Results

    Tebbutt NC, Norman A, Cunningham D, Iveson T, Seymour M, Hickish T, Harper P, Maisey N, Mochlinski K, Prior Y, Hill M, A multicentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer., Ann. Oncol., 2002, 13, 10, 1568-1575.

Additional files

Editorial Notes