4 Versus 6 Courses of Adjuvant Chemotherapy in LACC Patients Previously Treated With NACT Plus Radical Surgery

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators primary outcome was to evaluate the effectiveness in term of Overall Survival (OS) and disease free interval (DFI) of two different platinum-based chemotherapic regimen (3 and 6 cycles) for treatment of Locally Advanced Cervical Cancer (LACC) (IB2-IIB) previously treated with Neoadjuvant Chemotherapy Plus Radical Surgery (NACT+RS).

The secondary outcome was to evaluate and compare safety, in term of toxicity profile, of the two treatment options.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Campus Bio-Medico University
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• patients with squamous cell, adenosquamous or adenocarcinoma of the cervix

• Stage IB2-IIB according to the Inyernational Federation of Gynecology and Obstetrics (FIGO)

• age between 18 and 75 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• normal cardiac and respiratory functions

• absence of secondary malignancies

• no previous surgical, chemotherapic and/or radiotherapic treatment for secondary malignancies

• informed consent obtained from the patient.

Exclusion Criteria:

• histological confirmation of papillary serous, mucinous, clear cell, squamous cell, mixed and undifferentiated carcinoma of the uterus

• abnormal hepatic function (transaminases > 2.5 x upper limit, serum bilirubin > 1,5 x upper limit)

• abnormal renal function (creatinine clearance <60 mL/min and/or serum creatinine>2.0 mg/100 mL) function

• abnormal bone marrow function (absolute neutrophil count <1,5 x 109/L or platelet count < 100 x 109/L or hemoglobin < 9 g/dL

• severe or uncontrolled infection, other systemic diseases or mental illness; and

• pregnant women. Clinical staging was performed according to the NCCN criteria, and included pelvic examination, cervical biopsy, abdomen-pelvis Computed Tomography, chest X-ray; examination under anesthesia, cystoscopy and/or proctoscopy if clinically indicated (National Comprehensive Cancer Network, Clinical Practicw Guidelines in Oncology. Cervical Cancer, Version 2.2015)