Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients

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

Summary

This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.

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

Details

• Lead Sponsor: xie congying
• Treatments: Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

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

• Negative lymph node

• At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve 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