VMAT Concurrent Cisplatin Plus Nab-paclitaxel for Local Advanced Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT04017377|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: Drug: Cisplatin; nab-paclitaxel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer|
|Estimated Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||June 15, 2020|
|Estimated Study Completion Date :||July 15, 2020|
Experimental: Chemotherapy+ Radiation therapy
Chemotherapy: Patients firstly receive an escalating dose of weekly Nab-paclitaxel starting at 10 mg/m^2 up to 70 mg/m^2, Patients secondly receive weekly cisplatin (40 mg/m^2). Treatment repeats every week until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. Concurrent chemotherapy is a weekly regimen during radiotherapy. Patients will complete at least 4 cycles of concurrent chemoradiotherapy, until the maximal tolerated dose (MTD) appeared.
Radiation therapy: Patients also receive pelvic radiation therapy once daily (Monday-Friday) for a total of 28 fractions and intracavitary brachytherapy twice a week for a total 5 fractions. Complete radiotherapy within 55 days.
Drug: Drug: Cisplatin; nab-paclitaxel
Drug: Paclitaxel for Injection（Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)
- Maximum Tolerated Dose(MTD)/Recommended Dose(RD) [ Time Frame: Up to 5 weeks ]Maximum Tolerated Dose (MTD) will be defined during the Dose Escalation Stage based on evaluation of the number of patients with Dose-limiting Toxicity (DLT). The MTD will be used to determine the Recommended Dose (RD).
- Number of patients with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 5 weeks ]Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions.
- Objective response rate (ORR) [ Time Frame: Up to 5 weeks ]ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR.
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): NCT04017377
|Contact: Junjie Wang, MD, PhDemail@example.com|
|Contact: Ping Jiang, MDfirstname.lastname@example.org|
|Principal Investigator:||Junjie Wang, MD, PhD||Peking University Third Hospital|