Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|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|
- disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]assessed by NCI Common Terminology Criteria v3.0
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 2
Patients receive radiotherapy alone as in arm 1.
Experimental: Arm 1
Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area.
|Drug: paclitaxel Drug: cisplatin Radiation: Radiotherapy|
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.
|Contact: congying xie, MDfirstname.lastname@example.org|
|The First Affiliated Hospital of Wenzhou Medical College||Recruiting|
|Wenzhou, Zhejiang, China, 325000|
|Contact: congying xie, MD +86-577-88069316 email@example.com|
|Principal Investigator: congying xie, MD|
|Study Director:||Congying Xie, MD||the 1st Affiliated Hospital of Wenzhou Medical College|