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

Cervical Cancer Clinical Trial

Official title:

Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01755845
• Other study ID #: WZMC-11256
• Status: Recruiting
• Phase: Phase 3
• First received: December 19, 2012
• Last updated: April 27, 2016
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Wenzhou Medical University
• Contact: congying xie, MD
• Phone: +86-577-88069316
• Email: wzxiecongying[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis.

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.

Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• paclitaxel

• cisplatin

Radiation:
• radiotherapy

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
xie congying

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events as a measure of safety and tolerability	assessed by NCI Common Terminology Criteria v3.0	1 year	Yes
Primary	disease-free survival		3 years	No
Secondary	overall survival		5 years	No