ADVANCED UTERINE CERVICAL CARCINOMA MedDRA version: 21.1 Level: PT Classification code 10055094 Term: Cervix cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CISPLATINO
Product Code: [CISPLATINO]
Pharmaceutical Form:
INN or Proposed INN: CISPLATINO
CAS Number: 15663-27-1
Current Sponsor code: CISPLATINO
Concentration unit: mg milligram(s)
Co
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age =18, ECOG 0-2, histological diagnosis of cervical cancer, stage FIGO IB2- IVA (stage 2009) + positive pelvic and/or aortic lymph nodes, absence of oncological pretreatment, informed consent, sufficient medullary, renal and hepatic function 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: Age 3, contraindications to radiotherapy (genetic hyper-radiosensitivity syndromes), contraindications to pelvic radiotherapy: ulcerative rectocolitis, acute diverticulitis, severe diverticulosis, chronic pelvic phgosis, previous pelvic radiotherapy, patient enrolled in another experimental study, presence of internistic pathologies that contraindicate the neoadjuvant chemotherapy treatment, radiochemotherapy or surgery (severe liver disease, cardiopathy, kidney failure, etc.), presence of other neoplasm, any significant medical condition which in the opinion of the investigator may interfere with the optimal participation of the patient in the study, use of antibiotics for at least 4 weeks prior to sample collection,alcoholic patient, diseases that affect gastrointestinal motility such as scleroderma, insulin-dependent diabetes and /or uncontrolled diabetes (Hgb-A1c> 8%), clinically significant dehydration, clinically detectable ascites, sepsis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the histopathological complete response to the integrated treatment;Secondary Objective: Assessment of clinical response to integrated treatment using MRI and PET-TAC imaging with 18FDG Late and acute toxicity assessment Assessment of local control, disease-free survival and overall survival Evaluation of the quality of life;Primary end point(s): Assessment of the histopathological complete response to the integrated treatment;Timepoint(s) of evaluation of this end point: 36 MONTHS | — |
Countries
Italy
Contacts
Public ContactDIREZIONE SCIENTIFICA
POLICLINICO A. GEMELLI ROMA IRCCS
Outcome results
None listed