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About
This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes.
Full description
This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes.
Patients
The primary objective is to evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
PART 1:
Inclusion Criteria:
Exclusion Criteria:
PART 2:
Inclusion Criteria:
Maintained consent
Adequate hematologic function: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10g/dL
Adequate renal function: creatinine clearance (estimated according to MDRD formula) ≥ 60ml/min/1.73m2
Adequate hepatic function: Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤ 2.5 × upper normal limit (UNL); Total bilirubin ≤ 1.5 x UNL (except in case of Gilbert's disease)
Patient having received curative intent chemo-radiation therapy with the following recommendations:
Exclusion Criteria:
Progression during Part 1,
Contraindication for one of the study drug in particular the residual toxicity of Part 1 (radio-chemotherapy) such as:
Radiation therapy prematurely stopped (total dose on whole pelvis and on nodes not received)
Cumulative dose of Cisplatin received less than 120 mg/m².
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
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Central trial contact
Alicia Probst
Data sourced from clinicaltrials.gov
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