E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High risk and advanced stage endometrial carcinoma |
Carcinoma dell'endometrio ad alto rischio di recidiva o avanzato |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014759 |
E.1.2 | Term | Endometrial neoplasm |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
The primary objective of this study is to establish overall survival and failure-free survival of patients with high-risk and advanced stage endometrial carcinoma treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone |
sopravvivenza globale e libera da recidiva per pazienti con carcinoma dell endometrio ad alto rischio e in fase avanzata, trattate dopo chirurgia con radioterapia e chemioterapia concomitante ed adiuvante in confronto a pazienti trattate con sola radioterapia pelvica |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are to establish and compare the rates of pelvic and distant recurrence, severe (grades 3 and 4) treatment-related toxicity, and quality of life. |
tossicita' correlata al trattamento,qualita' della vita,recidive pelviche e a distanza |
|
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 |
LIFE QUALITY: Vers: Date: Title: Objectives:
|
QUALITA DELLA VITA: Vers: Data: Titolo: Obiettivi:
|
|
E.3 | Principal inclusion criteria |
Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO stages (confirmed at pathology review, see section 8.1): a. Stage IB grade 3 with documented lymph-vascular space invasion (LVSI) b. Stage IC grade 3 c. Stage II (occult) grade 3 d. Stage IIIA* or IIIC *IIIA based on peritoneal cytology alone is only eligible if grade 3 e. Stage IB, IC, II or III with serous or clear cell histology 2. Recommended surgery is TAH-BSO (total abdominal hysterectomy and bilateral salpingooophorectomy). However, for a patient who has had lymphadenectomy and/or full surgical staging, and was found after PA diagnosis to meet the eligibility criteria, inclusion in the trial is permitted. 3. WHO-performance status 0-2 4. WBC ≥ 3.0 x 109/L. 5. Platelets ≥ 100 x 109/L. |
Carcinoma endometrioide confermato istologicamente con una delle seguenti caratteristiche postoperatorie (stadio e grado FIGO) 1. stadio IB G3 con infiltrazione degli spazi linfovascolari 2. stadio IC G3 3. stadio II (occulto) G3 4. stadio IIIA o III C (IIIA per sola citologia solo se G3) 5. stadio IB o IC, II o III con istologia sierosa o a cellule chiare WHO PS 0-2 WBC > 3.0 x 109/l piastrine > 100 x 109/l bilirubina > 1.5 x UNl ASAT/ALAT > 2.5 UNl consenso informato scritto |
|
E.4 | Principal exclusion criteria |
1. Uterine sarcoma 2. History of any previous malignancy, except for basal cell carcinoma of the skin, within the last 10 years 3. Previous pelvic radiotherapy 4. Hormonal therapy or chemotherapy for this tumor 5. Macroscopic stage IIB for which radical (Wertheim type) hysterectomy has been performed 6. Prior diagnosis of Crohn s disease or ulcerative colitis 7. Residual macroscopic tumor after surgery 8. Impaired renal function: creatinine clearance ≤ 60 ml/min (calculated according to Cockroft) or ≤ 50 ml/min (EDTA clearance, or measured creatinine clearance) 9. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy 10. Peripheral Neuropathy > grade 2 |
pregresse neoplasie maligne negli ultimi 10 anni (escluso il basalioma cutaneo) pregressa radioterapia pelvica terapia ormonale o chemioterapia per questa malattia stadio IIB macroscopico (richiede isterectomia radicale) morbo di Crohn o colite ulcerosa tumore residuo macroscopico dopo chirurgia clearance della creatinina < 60 ml/min (sec. Cockroft) o < 50 ml/min (EDTA clearance, o clearance della creatinina calcolata) insufficienza cardiaca che impedisca adeguata idratazione durante la terapia con platino neuropatia periferica > G2 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival and failure-free survival |
sopravvivenza globale e libera da malattia |
|
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 | No |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 24 |
E.8.5 | The trial involves multiple Member States | Yes |
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 | No |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
|
endpoint: sopravvivenza a 5 anni con analisi da effettuarsi dopo l'osservazione di 215 eventi |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |