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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426056
• Other study ID #: M2024240
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: October 2028

Study information

• Verified date: April 2024
• Source: Peking University Third Hospital
• Contact: Ping Jiang, doctor
• Phone: 86010-82266699
• Email: jiangping[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: October 2028
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

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).
• Cisplatin
Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Peking University Third Hospital	Affiliated Hospital of Hebei University, Hebei Medical University Fourth Hospital, Jilin Provincial Tumor Hospital

Outcome

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