Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer

Trial details

Who runs it

Centre Oscar Lambret

Trial code

NCT04016142

Record updated

2026. március 18.

Original 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.Read full original descriptionShow less

Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes

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.

Inclusion: Female patient aged more than 18 years old; Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix; With locally advanced cervical cancer (FIGO stage IIIC2); With para-aortic or iliac common nodes positive on PET-scan or after laparoscopic surgical staging if PET-scan negative; ECOG Performance Status ≤ 2; 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); Negative serum pregnancy test within 7 days prior to treatment for women of childbearing potential. For non-menopaused women, if not surgically sterilized, willing to accept the use of an effective contraceptive regimen during the treatment period and at least 6 months after the end of treatment; Absence of contraindication to receive the products used in this study (products used in concomitant/ adjuvant chemotherapy) according to the most recent SmPC of these products (available at http://base-donnees-publique.medicaments.gouv.fr/); Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up; Patient covered by the French "Social Security" regime; Signed informed consent form; 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:; extended field CT-RT delivered by IMRT: 45-50Gy according the dosimetry limitation histogram dose volume (HDV) in whole pelvis and Para Aortic volumes + concomitant boost on macroscopic nodes defined as PET-positive; associated with weekly Cisplatin (40mg/m²); followed by image guided brachytherapy. Patient will be eligible even in case of temporary stop of radiation therapy, provided she has received a total dose of 45Gy and a concomitant boost. Patient should have received at least 3 injections of Cisplatin 40mg/m² during radiation therapy.

Exclusion: Previous hysterectomy or planned hysterectomy as part of their initial cervix cancer therapy,; Prior diagnosis of Crohn's disease or ulcerative colitis or sclerodermia; Radiation therapy prematurely stopped (total dose on whole pelvis and on nodes not received); Cumulative dose of Cisplatin received less than 120 mg/m²; Patient with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years; Other uncontrolled intercurrent disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation; Participation in another therapeutic trial with an experimental molecule for the current disease; Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent; Contraindication for one of the study drug in particular the residual toxicity of Part 1 (radio-chemotherapy) such as:; Renal failure (defined as creatinine clearance according to MDRD formula < 60 mL/ min/1.73m2),; Any clinical residual toxicity (including peripheral neuropathy) ≥ grade 2 (as per CTCAE v5),; Histological diagnosis of sarcoma; Presence of distant metastases other than lombo-aortic lymph nodes; Patient with bilateral hydronephrosis unless at least one side has been stented; Pregnant or breastfeeding woman,; Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons); Person under guardianship or curatorship; PART 2:; Progression during Part 1,.

PART 1:.

ClinicalTrials.gov NCT04016142