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

Cervical Cancer Clinical Trial

Official title:

Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01756170
• Other study ID #: WZMC-11352
• Status: Recruiting
• Phase: Phase 3
• First received: December 13, 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

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.

Description:

Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. However, the treatment modality in patients with low-risk (lymph node negative) is still disputable. It is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• 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 (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

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