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Clinical Trials/ISRCTN54178182
ISRCTN54178182
Completed
N/A

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

Medical Research Council (MRC) (UK)0 sites1,000 target enrollmentApril 6, 2000
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ConditionsCervix cancerCancerCervix

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervix cancer
Sponsor
Medical Research Council (MRC) (UK)
Enrollment
1000
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 6, 2000
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Medical Research Council (MRC) (UK)

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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