Stage IIA-III carcinoma of the uterine cervix. MedDRA version: 8.1 Level: LLT Classification code 10041848 Term: Squamous cell carcinoma of the cervix
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg/ml milligram(s)/millili
Sponsors
Department of Gynecological Oncology, University Hospital, Örebro
Eligibility
Sex/Gender
All
Inclusion 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 >= 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 = 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
Exclusion criteria
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; [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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Sweden
Outcome results
None listed