| 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) |
| Primary Purpose: | Treatment |
| Official Title: | Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | June 15, 2020 |
| Estimated Study Completion Date : | July 15, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
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)
|
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Junjie Wang, MD, PhD | 13701076310 | junjiewang_edu@sina.cn | |
| Contact: Ping Jiang, MD | 13439796018 | jp7962@sohu.com |
| China, Beijng | |
| Peking University 3rd Hospital | Recruiting |
| Beijing, Beijng, China, 100191 | |
| Contact: Junjie Wang, MD 010-82266699 ext 5920 junjiewang_edu@sina.cn | |
| Principal Investigator: | Junjie Wang, MD, PhD | Peking University Third Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 9, 2019 | ||||||||
| First Posted Date ICMJE | July 12, 2019 | ||||||||
| Last Update Posted Date | April 28, 2020 | ||||||||
| Actual Study Start Date ICMJE | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | June 15, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | VMAT Concurrent Cisplatin Plus Nab-paclitaxel for Local Advanced Cervical Cancer | ||||||||
| Official Title ICMJE | Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer | ||||||||
| Brief Summary | This is a single arm, open-lable Phase I clinical trial. Eligible patients will have Histologically proven stage IB2-IVA cervical cancer. We hypothesize that Nab-paclitaxel in combination with cisplatin and radiotherapy may have anti-tumor activity in patients with cervical cancer. Nab-paclitaxel has not previously been combined with conventional RT-CT to treat cervical cancer. | ||||||||
| Detailed Description | During the phase I study, patients will receive radiation therapy to pelvis (50.4 Gy in 28fractions), and followed by HDR intracavitary (30Gy in 5 fractions) brachytherapy. Concurrent chemotherapy was administered with weekly cisplatin (40 mg/m^2) and an escalating dose of weekly Nab-paclitaxel starting at 10 mg/m^2 up to 70 mg/m^2. Chemotherapy agents were administered in escalating doses to cohorts of three patients at each dose level. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Cervical Cancer | ||||||||
| Intervention ICMJE | Drug: Drug: Cisplatin; nab-paclitaxel
Drug: Paclitaxel for Injection(Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)
|
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| Study Arms ICMJE | 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. Intervention: Drug: Drug: Cisplatin; nab-paclitaxel
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
15 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 15, 2020 | ||||||||
| Estimated Primary Completion Date | June 15, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04017377 | ||||||||
| Other Study ID Numbers ICMJE | M2019163 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Junjie Wang, Peking University Third Hospital | ||||||||
| Study Sponsor ICMJE | Peking University Third Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Peking University Third Hospital | ||||||||
| Verification Date | April 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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