Cetuximab and cisplatin in addition to radiotherapy in the treatment of stage IIA-III carcinoma of the uterine cervix - a pilot phase II study.
- Conditions
- Stage IIA-III carcinoma of the uterine cervix.MedDRA version: 8.1Level: LLTClassification code 10041848Term: Squamous cell carcinoma of the cervix
- Registration Number
- EUCTR2006-003759-19-SE
- Lead Sponsor
- Department of Gynecological Oncology, University Hospital, Örebro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
[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 >=
1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 100 g/L;
[9]Adequate hepatic and renal function: S-bilirubin, total <= 1.5 x UNL,
S-ALAT and S-ASAT <= 3.0 x UNL, S-ALP <= 5.0 x UNL, and S-creatinine <=
1.5 x UNL. S-albumin, S-sodium, S-potassium, S-calcium, S-magnesium,
S-urea, and S-urate within normal reference limits. GFR >= 60 ml/min
(calculated or measured);
[10]Written informed consent;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[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;
[17]Second primary malignancy (except an adequately treated basal cell
carcinoma of the skin) unless treated, in remission and off active
treatment for more than 5 years;
[18]Investigator site personnel directly affiliated with the study, or their
immediate family;
[19]Simultaneous treatment with experimental drugs or participation in a
clinical trial within 30 days of study entry;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Loco-regional tumor control (based on a clinical and gynecological examination, an examination under anesthesia as well as a vaginal and/or abdominal ultrasound) at 4 months after the end of treatment with chemoradiotherapy and cetuximab.;Secondary Objective: Recurrence-free survival, relapse pattern, overall survival, and toxicity.;Primary end point(s): Loco-regional tumor control (based on a clinical and gynecological examination, an examination under anesthesia as well as a vaginal and/or abdominal ultrasound) at 4 months after the end of treatment with chemoradiotherapy and cetuximab.
- Secondary Outcome Measures
Name Time Method