A randomised trial of chemotherapy and radiotherapy versus radiotherapy alone as adjuvant treatment in women with node positive operable cancer of the cervix

Completed

• Conditions: Cervix cancer; Cancer; Cervix

• Registration Number: ISRCTN54178182
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

1. Histologically confirmed cancer of the cervix with: Squamous, adenosquamous or adencarcinoma cell type/International Federation of Gynecology and Obstetrics (FIGO) stage IB or IIA/Nodal involvement (of any extent)
2. Patient fit to receive, and with no contraindication to, cisplatin-based chemotherapy
3. Patient should have undergone a radical hysterectomy, a pelvic lymphadenectomy and resection of any suspicious (enlarged) common iliac or para-aortic lymph nodes where appropriate
4. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons
5. Written informed consent

Exclusion Criteria

1. WBC less than 3.5 x 10 to the power of 9 per litre
2. Platelets less than 100 x 10 to the power of 9 per litre
3. Bilirubin more than 1.25 times the upper limit of normal
4. Glomerular filtration rate less than 50 millilitres per minute
5. Uncontrolled or potentially active site of infection (eg fistula or abscesses)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is survival, defined as time from randomisation to death (from any cause).

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are progression-free survival, site of relapse, toxicity-free survival and quality of life.