Overview

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)