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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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 3 years, with 3 years of follow up period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborator: Institut Claudius Regaud
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel

Criteria

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 <2.0mg/dl)

• Adequate hepatic function (bilirubin <1.5 times normal and Serum Glutamooxaloacetate Transferase < 3 times normal)

• Adequate hematopoietic function Platelet count > 75x10 9/l and Absolute neutrophil count > 1X10 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