A study of potentially curative local therapy alone, or preceded by chemotherapy, in the treatment of Stage Ib-IVa cervical carcinoma

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN79554459
• Date of registration: 28/02/2001
• Prospective Registration: No
• Primary sponsor: Medical Research Council (MRC) (UK)
• Public title: A study of potentially curative local therapy alone, or preceded by chemotherapy, in the treatment of Stage Ib-IVa cervical carcinoma
• Date of first enrolment: 01/01/1991
• Target sample size: 313
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN79554459
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Max Parmar

Key inclusion & exclusion criteria

Inclusion criteria: 1. Histologically proven invasive cancer of the cervix Stage Ib through to IVa
2. Patients must be fit enough to receive adjuvant chemotherapy, and the chosen definitive treatment
3. World Health Organisation (WHO) performance status zero to one or creatinine clearance of at least 60 ml/min
4. The informed consent of the patient
Exclusion criteria: 1. Previous chemotherapy
2. Renal, hepatic or bone marrow dysfunction which in the opinion of the investigator is sufficient to prejudice therapy (including local treatment and chemotherapy
3. Previous malignancy other than basal cell carcinoma
4. Medical or psychological conditions precluding treatment

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical cancer
Cancer
Cervical cancer

Intervention(s)

Chemotherapy patients randomised to chemotherapy, will receive this treatment prior to local therapy. Chemotherapy will consist of: cisplatin (50 mg/m^2), methotrexate (100 mg/m^2) and folinic acid (15 mg orally every six hours, to commence 30 hours after the start of intravenous cisplatin and methotrexate, for eight doses). Cisplatin and methotrexate will be given intravenously for three cycles, once every two to three weeks depending upon tolerance. Adequate hydration should be given before and after administration of cisplatin. No immediate chemotherapy (local therapy). Because of the diversity of approach with regard to surgery and especially radiotherapy, no specific schedule will be laid down.

However all patients entering the study should receive radical local treatment which is regarded as potentially curative within that situation. Ideally, each institution should use a standard treatment policy throughout the study. Local therapy should be started as soon as possible after diagnosis or within three weeks of completing chemotherapy in those patients randomised to chemotherapy.

Primary Outcome(s)

Survival and time to recurrence

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

CeCa

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)