Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01756170|
Recruitment Status : Unknown
Verified April 2016 by xie congying, Wenzhou Medical University.
Recruitment status was: Recruiting
First Posted : December 25, 2012
Last Update Posted : April 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: paclitaxel Drug: cisplatin Radiation: Radiotherapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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|
- disease-free survival [ Time Frame: 3 years ]
- overall survival [ Time Frame: 5 years ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]assessed by NCI Common Terminology Criteria v3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756170
|Contact: congying xie, MDemail@example.com|
|The First Affiliated Hospital of Wenzhou Medical College||Recruiting|
|Wenzhou, Zhejiang, China, 325000|
|Contact: congying xie, MD +86-577-88069316 firstname.lastname@example.org|
|Principal Investigator: congying xie, MD|
|Study Director:||Congying Xie, MD||the 1st Affiliated Hospital of Wenzhou Medical College|