Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread

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 Criteria:

* 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 Criteria:

* 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

Conditions2

Interventions3

Related trials

• A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors — CStone Pharmaceuticals
• A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors — Mabwell (Shanghai) Bioscience Co., Ltd.
• A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer — Shanghai Jiao Tong University School of Medicine
• A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy — Tianjin Medical University Cancer Institute and Hospital
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC — Sichuan Baili Pharmaceutical Co., Ltd.
• A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma — Renmin Hospital of Wuhan University
• A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer — Peking University Cancer Hospital & Institute

Browse More Trials