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

NCT02365935 | Completed

• 1 other identifier: CC/47 cbm
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasms

Keywords

adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• overall survival

  To evaluate the effectiveness in term of overall survival of two different platinum-based chemotherapic regimen (4 and 6 cycles) for treatment of LACC (IB2-IIB) previously treated with NACT+RS.

  up to 6 years

Secondary Outcomes (2)

• safety:to evaluate and compare safety, in term of toxicity profile, of the two adjuvant treatment options.

  up to 6 years

• disease free interval

  up to 6 years

Study Arms (2)

Group A to administer 4 cycles

EXPERIMENTAL

In Group A, all patients received 4 cycles of adjuvant chemotherapy every three weeks according to the scheme Cisplatin 100 mg/mq and Paclitaxel 175 mg/mq.

Procedure: Group A adjuvant chemotherapy; Drug: Cisplatin; Drug: Paclitaxel

Group B to administre 6 cycles

EXPERIMENTAL

In Group B, all patients received instead 6 cycles of adjuvant chemotherapy every three weeks according to the same chemotherapic regimen.

Procedure: Group B adjuvant chemotherapy; Drug: Cisplatin; Drug: Paclitaxel

Interventions

Group A adjuvant chemotherapy PROCEDURE

In Group A, all patients received 4 cycles of adjuvant chemotherapy every three weeks according to the scheme Cisplatin 100 mg/mq and Paclitaxel 175 mg/mq.

Also known as: 4 cycles

Group A to administer 4 cycles

Group B adjuvant chemotherapy PROCEDURE

In Group B, all patients received 6 cycles of adjuvant chemotherapy every three weeks according to the scheme Cisplatin 100 mg/mq and Paclitaxel 175 mg/mq.

Group B to administre 6 cycles

Cisplatin DRUG

Group A to administer 4 cycles; Group B to administre 6 cycles

Paclitaxel DRUG

Group A to administer 4 cycles; Group B to administre 6 cycles

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

campus bio-medico of Rome

Rome, 00128, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Roberto Angioli, Professor

  Campus Bio Medico of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Roberto Angioli

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2014
• Last Updated: February 19, 2015

Record last verified: 2015-02

Locations

IT (1)