Cervical CancerPhase 2NCT06426056
Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial.
A Phase 2 study testing radiotherapy, Nab paclitaxel and Cisplatin in people with Cervical Cancer, run by Peking University Third Hospital.
Trial summary
Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced 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?
- radiotherapy, Nab paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- (1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system;
- (2) Eastern Cooperative Oncology Group at 2 or less;
- (3) Life expectancy of greater than 3 months;
- (4) Left ventricular ejection fraction at ≥55%;
- (5) Neutrophil count at ≥1500/mm^3, platelet count at ≥100,000/mm^3 or hemoglobin at ≥9.0 g/dL;
- (6) Serum creatinine at <1.5 times the upper limit of the normal reference range;
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- (7) Alanine transaminase or aspartate aminotransferase at >2.5 times the upper limit of the normal reference range;
- (8) Non pregnant or lactating women;
- (9) Women of childbearing age willing to adopt reliable contraceptive measures;
- (10) Sign informed consent form.
Who cannot join
- (1) Individuals who have previously received chemotherapy with albumin bound paclitaxel;
- (2) Individuals who have previously received abdominal or pelvic radiation therapy;
- (3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy;
- (4) Individuals with central nervous system diseases or brain metastases；
- (5) Other malignant tumors other than cervical cancer have appeared within the past 5 years;
- (6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ;
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- (7) The researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc;
- (8) known to be allergic to paclitaxel;
- (9) Received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration;
- (10) Serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia;
- (11) Human immunodeficiency virus (HIV) positive individuals;
- (12) Uncontrolled or active viral hepatitis or infection with human immunodeficiency virus;
- (13) Researchers determine that it is not suitable to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial.
Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- radiotherapy, Nab paclitaxel, Cisplatin
- 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.
radiotherapyRadiation
Also called RT
Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week.
Nab paclitaxelDrug
Also called paclitaxel for injection (albumin bound)
Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).
CisplatinDrug
Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week). Receives: Radiation: radiotherapy; Drug: Nab paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (objective response rate)
ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants
Measured: the 1, 3, 6, 9, 12 months after the end of the treatment
Secondary outcomes (6)
AE
adverse events
Measured: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
OS
objective response rate
Measured: the 1, 2, and 3 years after the end of the treatment
PFS
progression-free survival
Measured: the 1, 2, and 3 years after the end of the treatment
DOR
duration of response
Measured: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
DCR
disease control rate
Measured: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
CBR
clinical benefit rate
Measured: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2028 (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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jilin Provincial Tumor Hospital, Affiliated Hospital of Hebei University, Hebei Medical University Fourth Hospital
- Responsible party
- Sponsor
- Investigators
- Ping Jiang, Doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426056
- Sponsor's protocol ID
- M2024240
- Status last verified
- Apr 2024
- First submitted
- 17 May 2024
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial.
- ClinicalTrials.gov ID
- NCT06426056
- Acronym / sponsor ID
- M2024240
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Jilin Provincial Tumor Hospital, Affiliated Hospital of Hebei University, Hebei Medical University Fourth Hospital
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 May 2024 (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.
Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: radiotherapy, Drug: Nab paclitaxel, Drug: CisplatinImage guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- (1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system;
- (2) Eastern Cooperative Oncology Group at 2 or less;
- (3) Life expectancy of greater than 3 months;
- (4) Left ventricular ejection fraction at ≥55%;
- (5) Neutrophil count at ≥1500/mm^3, platelet count at ≥100,000/mm^3 or hemoglobin at ≥9.0 g/dL;
Key exclusion criteria (13 listed)
- (1) Individuals who have previously received chemotherapy with albumin bound paclitaxel;
- (2) Individuals who have previously received abdominal or pelvic radiation therapy;
- (3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy;
- (4) Individuals with central nervous system diseases or brain metastases；
- (5) Other malignant tumors other than cervical cancer have appeared within the past 5 years;
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 |
|---|---|---|
| radiotherapyAlso: RTImage guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. | Radiation | Experimental group |
| Nab paclitaxelAlso: paclitaxel for injection (albumin bound)Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week). | Drug | Experimental group |
| CisplatinConcurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week). | Drug | Experimental group |
Primary outcome
ORR (objective response rate)
Time frame: the 1, 3, 6, 9, 12 months after the end of the treatment
ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants
6 secondary outcomes
AE
Time frame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
OS
Time frame: the 1, 2, and 3 years after the end of the treatment
PFS
Time frame: the 1, 2, and 3 years after the end of the treatment
DOR
Time frame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
DCR
Time frame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
CBR
Time frame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- 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.
Ping Jiang, Doctor principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiotherapy, Nab paclitaxel and Cisplatin in people with Cervical Cancer, run by Peking University Third Hospital.
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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ping Jiang, doctor (86010-82266699, jiangping@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (objective response rate) (time frame: the 1, 3, 6, 9, 12 months after the end of the treatment). 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 23 May 2024.