Clinical trial NCT06426056: Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial.
Official title: Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Jilin Provincial Tumor Hospital
name: Affiliated Hospital of Hebei University
name: Hebei Medical University Fourth Hospital
First posted: 2024-05-23
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: ORR (objective response rate)
timeFrame: the 1, 3, 6, 9, 12 months after the end of the treatment
Secondary outcomes:
measure: AE
timeFrame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
measure: OS
timeFrame: the 1, 2, and 3 years after the end of the treatment
measure: PFS
timeFrame: the 1, 2, and 3 years after the end of the treatment
measure: DOR
timeFrame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
measure: DCR
timeFrame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
measure: CBR
timeFrame: the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Ping Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: