E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IIA-III carcinoma of the uterine cervix. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041848 |
E.1.2 | Term | Squamous cell carcinoma of the cervix |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Recurrence-free survival, relapse pattern, overall survival, and toxicity. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The sub-study is integrated into the main clinical protocol and there is an appendix IV (Exploratory study) to the main study with details. Consequently it is following the same date and version as the main study (Final version, 2006-10-24). The objective of the exploratory study is to collect tumor tissue specimens and blood (serum) samples from the patients, in order to explore the relationship between treatment outcome and EGFR expression, the malignancy grading scores, interaction between tumor cells and fibroblasts, and the multiprotein expression patterns in tumor tissue and in the serum. |
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E.3 | Principal 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 <= 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; |
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E.4 | Principal 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; |
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E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject after follow-up for 3 completed years or until death. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |