Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Radiation: radiotherapy; Drug: Nab paclitaxel; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ping Jiang, doctor; Phone Number: 86010-82266699; Email: jiangping@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; 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).

Radiation: radiotherapy; 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.; Other Names: RT; Drug: Nab paclitaxel; Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).; Other Names: paclitaxel for injection (albumin bound); Drug: Cisplatin; Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR (objective response rate)	ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants	the 1, 3, 6, 9, 12 months after the end of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	adverse events	the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
OS	objective response rate	the 1, 2, and 3 years after the end of the treatment
PFS	progression-free survival	the 1, 2, and 3 years after the end of the treatment
DOR	duration of response	the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
DCR	disease control rate	the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment
CBR	clinical benefit rate	the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Jilin Provincial Tumor Hospital; Affiliated Hospital of Hebei University; Hebei Medical University Fourth Hospital
• Investigators: Principal Investigator: Ping Jiang, Doctor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: M2024240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No