Cervical CancerNCT04017377
VMAT Concurrent Cisplatin Plus Nab-paclitaxel for Local Advanced Cervical Cancer
A study testing Drug: Cisplatin; nab-paclitaxel in people with Cervical Cancer, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Drug: Cisplatin; nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years.
- Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): Federation of Gynecology and Obstetrics (FIGO) clinical stages IB2-IVA.
- At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- The expected survival after surgery ≥ 3 months;
- LVEF≥55%;
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- Bone marrow function: Neutrophils ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L, and hemoglobin ≥ 90 g/L;
- Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
- Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age;
- Women must not lactate;
- Signed informed content obtained prior to treatment；
Who cannot join
- Patients previously treated with nab-paclitaxel;
- Patients previously undergoing abdominal or pelvic radiotherapy；
- Patients with CNS diseases or brain metastases；
- Other malignant tumors other than cervical cancer occurred in the past 5 years；
- Patients who had Grade 2 or above Peripheral neuropathy；
- Patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program, For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc；
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- Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires；
- History of allergy or hypersensitivity to any therapeutic ingredient；
- Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection；
- Previously received systemic therapy for advanced/metastatic pancreatic cancer;
- Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen；
- Patients who had Grade 2 or above Peripheral neuropathy；
- Known to be allergic, highly sensitive or intolerant to the study-related drugs or their excipients;
- Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period；
- Severe infections including, but not limited to, complications of infection, bacteremia or severe pneumonia that require hospitalization within 4 weeks of study treatment initiation；
- Subjects had hepatitis b surface antigen (HBsAg)-positive and HBV- DNA titer in peripheral blood greater than or equal to 1000 copy number /L; If HBsAg is positive and the peripheral blood HBV-DNA <1000 copy number /L, the subjects will be eligible for inclusion if the investigator considers that chronic hepatitis b is stable and does not increase the risk of subjects；
- Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients；
- The researchers considered that there were other conditions that were not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University 3rd Hospital
Beijing, Beijng, 100191
Junjie Wang, MD, 010-82266699 ext. 5920, junjiewang_edu@sina.cn
About this study
Official title: Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Drug: Cisplatin; nab-paclitaxel
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Cisplatin; nab-paclitaxelDrug
Drug: Paclitaxel for Injection（Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy+ Radiation therapy | Experimental | 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. Receives: Drug: Drug: Cisplatin; nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(MTD)/Recommended Dose(RD)
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).
Measured: Up to 5 weeks
Secondary outcomes (2)
Number of patients with Dose Limiting Toxicity (DLT)
Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions.
Measured: Up to 5 weeks
Objective response rate (ORR)
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.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2019
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Wang, Peking University Third Hospital
- Investigators
- Junjie Wang, MD, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017377
- Sponsor's protocol ID
- M2019163
- Status last verified
- Apr 2020
- First submitted
- 9 Jul 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT04017377
- Acronym / sponsor ID
- M2019163
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy+ Radiation therapy | Experimental | Drug: Drug: Cisplatin; nab-paclitaxelChemotherapy: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years and ≤ 75 years.
- Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): Federation of Gynecology and Obstetrics (FIGO) clinical stages IB2-IVA.
- At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- The expected survival after surgery ≥ 3 months;
Key exclusion criteria (18 listed)
- Patients previously treated with nab-paclitaxel;
- Patients previously undergoing abdominal or pelvic radiotherapy；
- Patients with CNS diseases or brain metastases；
- Other malignant tumors other than cervical cancer occurred in the past 5 years；
- Patients who had Grade 2 or above Peripheral neuropathy；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: Cisplatin; nab-paclitaxelDrug: Paclitaxel for Injection（Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing) | Drug | Chemotherapy+ Radiation therapy |
Primary outcome
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).
2 secondary outcomes
Number of patients with Dose Limiting Toxicity (DLT)
Time frame: Up to 5 weeks
Objective response rate (ORR)
Time frame: Up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Wang, MD, PhD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug: Cisplatin; nab-paclitaxel in people with Cervical Cancer, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junjie Wang, MD, PhD (13701076310, junjiewang_edu@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose(MTD)/Recommended Dose(RD) (time frame: Up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.