Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.

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

Details

• Lead Sponsor: xie congying
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)

• One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)

• Eastern Cooperative Oncology Group 0-2

• Expected life span over 6 months.

• No distant metastasis

• Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)

• Adequate renal functions(serum creatinine ≤ 1.5mg/dl)

• Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)

• Written informed consent

Exclusion Criteria:

• Previous history of chemotherapy or radiation

• Hypersensitive reaction to platinum/paclitaxel agent

• History of other cancer

• Concurrent systemic illness not appropriate for chemotherapy

• Active infection requiring antibiotics

• Pregnancy

• Metastasis to paraaortic lymph node