NCT04016142终止2 期
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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Progression Free Survival with adjuvant chemotherapy
研究概览
简要总结
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.
详细描述
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
- will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study").
- will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment).
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •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
排除标准
- •Histological diagnosis of sarcoma
- •Previous hysterectomy or planned hysterectomy as part of their initial cervix cancer therapy,
- •Presence of distant metastases other than lombo-aortic lymph nodes
- •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
- •Patient with bilateral hydronephrosis unless at least one side has been stented
- •Prior diagnosis of Crohn's disease or ulcerative colitis or sclerodermia
- •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
- •Pregnant or breastfeeding woman,
- •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
- •Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
- •Person under guardianship or curatorship
- •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:
- •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 Criteria:
- •Progression during Part 1,
- •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),
- •Radiation therapy prematurely stopped (total dose on whole pelvis and on nodes not received)
- •Cumulative dose of Cisplatin received less than 120 mg/m².
研究组 & 干预措施
Carboplatin-Paclitaxel adjuvant chemotherapy
Experimental
Patients
- will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study").
- will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment).
干预措施: Carboplatin-Paclitaxel adjuvant chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival with adjuvant chemotherapy
时间窗: From the date of inclusion in the Part 2 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 64 months.
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. Progression will be based on a MRI scan, done during the usual oncologic follow-up: every 3 months during the 2 first years after radio-chemotherapy, and then every 6 months during 3 years. Progression will be evaluated with RECIST criteria v1.1. The main analysis of this phase II trial will focus on the 2-year PFS rate from inclusion in the Part 2, but the whole curve will be estimated.
次要结局
- Number of Cycles Received of adjuvant chemotherapy(From the date of inclusion in the Part 2 of the study until the date of adjuvant chemotherapy ending or patient study output or death whatever the cause. Up to 4 months.)
- Overall Survival with concomitant chemo-radiotherapy associated to brachytherapy(From the date of inclusion in the Part 1 of the study until the date of death whatever the cause. Assessed up to 67 months.)
- Safety of the whole treatment(From the date of inclusion in the Part 1 of the study, up to 5 years after the end of radiation therapy or until progression (whichever occurs first).)
- Overall Survival with adjuvant chemotherapy(From the date of inclusion in the Part 2 of the study until the date of death whatever the cause. Assessed up to 64 months.)
- Metastasis Free Survival with adjuvant chemotherapy(From the date of inclusion in the Part 2 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 64 months.)
- Progression Free Survival with concomitant chemo-radiotherapy associated to brachytherapy(From the date of inclusion in the Part 1 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 67 months.)
- Metastasis Free Survival with concomitant chemo-radiotherapy associated to brachytherapy(From the date of inclusion in the Part 1 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 67 months.)
- Number of Cycles Received of concomitant chemo-radiotherapy associated to brachytherapy(From the date of inclusion in the Part 1 of the study until the date of concomitant chemo-radiotherapy associated to brachytherapy ending or patient study output or death whatever the cause. Assessed up to 12 weeks.)
研究者
研究点 (6)
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