Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
10/03/2015
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

- - -

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

G34

Study information

Scientific title

Comparison of radical radiotherapy with or without chemotherapy for poor prognosis carcinoma of cervix

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

Condition

Cervix cancer

Intervention

1. Arm A: Chemotherapy with methotrexate and cisplatinum repeated every 14 days for three cycles. Radiotherapy consisting of a course of external beam therapy followed by intracavity brachytherapy to start 14 days after the third course of chemotherapy. External beam therapy, a central tumour dose of 40 Gy in twenty fractions over 4 weeks. Intracavity brachytherapy, a dose of 32.5 Gy to point A in a single insertion.

2. Arm B: Radiotherapy consisting of a course of external beam therapy followed by intracavity brachytherapy to start as soon as possible following randomisation. External beam therapy, a central tumour dose of 40 Gy in twenty fractions over 4 weeks. Intracavity brachytherapy, a dose of 32.5 Gy to point A in a single insertion.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1992

Overall trial end date

24/08/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically diagnosed squamous cell carcinoma of the cervix uteri
2. International Federation of Gynecology and Obstetrics (FIGO) stage III, IVa or bulky stage II
3. No evidence of extra pelvic spread
4. Aged <70 years
5. World Health Organisation (WHO) performance 0-2
6. Suitable for radical radiotherapy
7. Suitable for chemotherapy
8. Adequate haematological and renal function
9. No history of previous malignancy, excluding successfully treated squamous and basal cell carcinoma of skin or carcinoma in situ of the cervix
10. No previous chemotherapy or radiotherapy
11. No contraindications to treatment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1992

Recruitment end date

24/08/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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