Postoperative Concurrent Chemoradiotherapy Combined With Endostar for High-risk Early Stage Cervical Cancer

Launched by NANJING MEDICAL UNIVERSITY · Aug 7, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with high-risk early-stage cervical cancer after surgery. Researchers want to see if combining a standard treatment of chemotherapy and radiation with a special drug called Endostar can help improve outcomes for patients. The goal is to find out if this combination is both effective and safe for women who have undergone surgery to remove their cervical cancer.

To be eligible for this trial, participants need to be between 18 and 70 years old and have a specific type of cervical cancer that has been surgically treated. They must have had a complete removal of the cancer with no remaining visible disease and have certain risk factors that make their cancer more likely to return. Participants will receive the new treatment after their surgery and will be closely monitored for any side effects or improvements. It’s important for potential participants to discuss their health history with their doctors to see if this trial is a good fit for them.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Aged between 18 and 70 years.
• • Histologically confirmed adenocarcinoma or squamous cervical carcinomas.
• • Chest CT scan and ultrasound must be done prior to surgery as to rule out distant metastasis.
• • Operable patients with clinical diagnosis of FIGO stage IB-IIA cervical cancer.
• • Complete radical hysterectomy of cervical cancer is mandatory. All gross diseases must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Para-aortic lymph node sampling is performed according to gynaecologist decision.
• • Patients with one of these risk factors:positive pelvic nodes, parametrial invasion, positive surgical margin.OR patients with at least two of following risk factors: tumor size≥4cm,lymphovascular space invasion,stromal invasion≥1/2.
• • Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group).
• • Adequate organ function is needed, including cardio-respiratory, hepato-renal and hematological reserves: Absolute neutrophil count (ANC)≥1.5×109/L;Platelet count≥100×109/L; ASAT\&ALST\<1.5 times upper limit of normal (ULN) (With hepatic metastases, ASAT\&ALST\<5.0 times upper limit of normal);Bilirubin \<1.5 times ULN;Creatinine≤1.25×ULN or Creatinine clearance≥50 mL/min.
• • Signed written informed consent prior to study entry.
• Exclusion Criteria:
• • Previous radiation or chemotherapy treatment or major pelvic surgery.
• • Patients with distant metastasis confirmed by imaging or pathology.
• • Other uncured malignant tumors in the past five years, except the cured skin basal cell carcinoma and breast carcinoma in situ.
• • Any prior anticancer therapy.
• • Unable to tolerate postoperative concurrent chemoradiotherapy.
• • Patients with evidence of being allergic to fluorouracil, cisplatin or Endostar.
• • Patients with serious comorbidity that might potentially influence the practice of protocol, including severe infection, myocardial infarction, severe arrhythmia, severe cerebrovascular disease, severe mental disorder, etc.
• • Patients with Heart related adverse events or thrombotic events in the past 6 months.
• • Patients with hepatitis B, hepatitis C and human immunodeficiency virus (HIV) or any other active viral infections.
• • Participate in other clinical researchers.
• • The estimated survival\<3 months;