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Trial Title:
Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial.
NCT ID:
NCT06426056
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
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.
Arm group label:
Experimental group
Other name:
RT
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly
nab-paclitaxel at escalating doses (33 mg/m^2 per week).
Arm group label:
Experimental group
Other name:
paclitaxel for injection (albumin bound)
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly
nab-paclitaxel at escalating doses (33 mg/m^2 per week).
Arm group label:
Experimental group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (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;
- (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.
Exclusion Criteria:
- (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) ;
- (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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 2024
Completion date:
October 2028
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
Jilin Provincial Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Hebei University
Agency class:
Other
Collaborator:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06426056
