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Clinical Trials/ISRCTN29976507
ISRCTN29976507
Completed
Not Applicable

Efficacy and toxicity of concomitant chemoradiation with weekly gemcitabine/cisplatin in comparison with weekly cisplatin in cervical cancer: a phase II, randomised trial

Shaheed Beheshti University of Medical Science (SBMU) (Iran)0 sites80 target enrollmentNovember 14, 2007
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ConditionsCervical cancer (FIGO stage IB, II , III, IVA)CancerCervical cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical cancer (FIGO stage IB, II , III, IVA)
Sponsor
Shaheed Beheshti University of Medical Science (SBMU) (Iran)
Enrollment
80
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 14, 2007
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Shaheed Beheshti University of Medical Science (SBMU) (Iran)

Eligibility Criteria

Inclusion Criteria

  • •1\. Women with untreated locally advanced cervical cancer International Federation of Gynaecology and Obstetrics (FIGO) stage IB, II, III, IVA
  • •2\. Histologically confirmed Squamous Cell Carcinoma (SCC)
  • •3\. Aged between 18 \- 70 years
  • •4\. Performance status less than or equal to 2 in Eastern Cooperative Oncology Group (ECOG) scale
  • •5\. No active co\-morbid illness (uncontrolled infection, cardiopulmonary disease, uncontrolled diabetes mellitus)
  • •6\. Laboratory data at start of chemotherapy:
  • •6\.1\. Haemoglobin (Hb) 12 g/dl or corrected to 11 g/dl before the start of therapy
  • •6\.2\. Platelets (Plt) 100 x 10^9/L
  • •6\.3\. Absolute Neutrophil Count (ANC) more than or equal to 1\.5 x 10^9/L
  • •6\.4\. Creatinine (Cr) less than or equal to 1\.5 x Upper Limit of Normal (ULN)

Exclusion Criteria

  • •1\. Any metastatic disease
  • •2\. Previous pelvic irradiation
  • •3\. History of other malignancy except non\-melanoma skin cancer
  • •4\. Disease out of the pelvis and para\-aortic lymph nodes

Outcomes

Primary Outcomes

Not specified

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