Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
Phase III Study Comparing Neoadjuvant Chemotherapy With Carboplatin and Paclitaxel Followed by Standard Therapy, With Standard Therapy Alone in Women With Cervical Cancer and Para Aortic Positive Lymph Node.
University Hospital, Toulouse
310 participants
Jul 17, 2020
INTERVENTIONAL
Conditions
Summary
The main objective of this study is to determine whether neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves overall survival rates compared to standard therapy alone in women with cervical cancer with paraaortic lymph node involvement. Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and paclitaxel every 21 days during 3 cycles followed by standard therapy with extended field external radiation therapy and concomitant chemotherapy. Women in the control arm will receive standard therapy with extended field external radiation therapy and concomitant chemotherapy. 310 patients will be recruited during 4.5 years, with 3 years of follow up period.
Eligibility
Inclusion Criteria8
- Women with histologically proven invasive carcinoma of the uterine cervix and para aortic lymphadenopathy determined by either a positive positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography or if negative positron emission tomography computed tomography based on histological examination of paraaortic lymph node dissection.
- Performance status Eastern Cooperative Oncology Group 0-2
- Stage International Federation of Gynecology and Obstetrics IB1 to IVA at diagnosis with para-aortic lymph node involvement
- Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma
- Adequate renal function (creatinine clearance ≥60 mL/min)
- Adequate hepatic function (bilirubin \<1.5 times normal and Serum Glutamooxaloacetate Transferase \< 3 times normal)
- Adequate hematopoietic function Platelet count \> 100x10 9/l and Absolute neutrophil count \> 1.5X10 9/l)
- Written Informed consent for participation
Exclusion Criteria8
- Stage Federation of Gynecology and Obstetrics IVB at diagnosis
- Others histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma.
- Women who receive any prior chemotherapy for her cervical cancer
- Pregnant or lactating women
- Prior ( within the last 5 years) malignancies other than non-melanoma skin cancer
- Inadequate renal, hepatic or hematopoietic function (Cf previously)
- Cardiovascular pathology New York Heart Association II or more
- Pre-existing Peripheral neuropathy Common toxicity Criteria grade ≥ 2
Interventions
carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
Cisplatin 40mg/m² given once a week during 5 weeks
45 gray to the pelvis and para aortic area over 5 weeks + intracavitary brachytherapy alone or prior to surgery, depending on response to treatment according to the current guidelines
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT03534713