Clinical trial · Interventional
4 Versus 6 Courses of Adjuvant Chemotherapy in LACC Patients Previously Treated With NACT Plus Radical Surgery
Phase II Randomized Controlled Trial on the Safety and Efficacy of 4 Versus 6 Courses of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients Previously Treated With Neoadjuvant Chemotherapy Plus Radical Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Group A adjuvant chemotherapy | Procedure | — | UNRESOLVED |
| Group B adjuvant chemotherapy | Procedure | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A to administer 4 cycles
- description
- 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.
- interventionNames
- Procedure: Group A adjuvant chemotherapy
- Drug: Cisplatin
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Group B to administre 6 cycles
- description
- In Group B, all patients received instead 6 cycles of adjuvant chemotherapy every three weeks according to the same chemotherapic regimen.
- interventionNames
- Procedure: Group B adjuvant chemotherapy
- Drug: Cisplatin
- Drug: Paclitaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
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