Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mei Shi
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• 18 Years to 70 Years

• Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy

• Accepted radical hysterectomy 3-4 weeks before

• Karnofsky score >70

• Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.

• Examination results showed no radiation or chemotherapy contraindication

• Willing to accept treatment

• Ability to comply with trial requirements

Exclusion Criteria:

• Postoperative residual

• Postoperative recurrence or metastasis

• Without lymph node dissection

• Postoperative pathology showed aortic lymph node metastasis

• Examination results showed radiotherapy contraindications

• No indications for radiotherapy