EUCTR2006-003759-19-SE
Active, not recruiting
Not Applicable
Cetuximab and cisplatin in addition to radiotherapy in the treatment of stage IIA-III carcinoma of the uterine cervix - a pilot phase II study.
Department of Gynecological Oncology, University Hospital, Örebro0 sitesNovember 1, 2006
ConditionsStage IIA-III carcinoma of the uterine cervix.MedDRA version: 8.1Level: LLTClassification code 10041848Term: Squamous cell carcinoma of the cervix
DrugsErbitux
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stage IIA-III carcinoma of the uterine cervix.
- Sponsor
- Department of Gynecological Oncology, University Hospital, Örebro
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\[1]Histological diagnosis of squamous cell carcinoma and adenocarcinoma of the uterine cervix;
- •\[2]Patients with stage IIA\-III disease according to the FIGO staging system;
- •\[3]\>\= 18 years old;
- •\[4]WHO performance status 0\-1;
- •\[5]Patients with a good general condition who are considered for primary
- •radiotherapy and expected to tolerate standard radiotherapy combined
- •with weekly cisplatin;
- •\[6]Estimated life expectancy of at least 12 weeks;
- •\[7]Patient compliance with follow\-up routines;
- •\[8]Adequate hematological function: WBC \>\= 3\.0 x 10^9/L, neutrophils \>\=
Exclusion Criteria
- •\[11]Prior surgery, radio\- or chemotherapy for carcinoma of the uterine cervix;
- •\[12]Patients who are considered eligible for primary surgery;
- •\[13]Evidence of active infection (at the discretion of the investigator);
- •\[14]Pregnancy or breast feeding, childbearing potential not using medically
- •accepted means of contraception;
- •\[15]Concurrent systemic disorder incompatible with the study, e.g. serious
- •intercurrent renal, cardiovascular or CNS disease, a major dysfunction in a
- •site of known or assumed toxic effects etc;
- •\[16]Known hypersensitivity to any active or inactive ingredient of the study
- •medications, or with hypersensitivity to murine proteins;
Outcomes
Primary Outcomes
Not specified
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