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

NCT06426056 | Not Yet Recruiting Phase 2

• 1 other identifier: M2024240
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• AE

  the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

• OS

  the 1, 2, and 3 years after the end of the treatment

• PFS

  the 1, 2, and 3 years after the end of the treatment

• DOR

  the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

• DCR

  the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

Study Arms (1)

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).

Radiation: radiotherapy; Drug: Nab paclitaxel; Drug: Cisplatin

Interventions

radiotherapy RADIATION

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.

Also known as: RT

Experimental group

Nab paclitaxel DRUG

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

Also known as: paclitaxel for injection (albumin bound)

Experimental group

Cisplatin DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Jilin Provincial Tumor Hospital: collaborator
• Affiliated Hospital of Hebei University: collaborator
• Hebei Medical University Fourth Hospital: collaborator

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy; Taxes; Paclitaxel; Injections; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Economics; Health Care Economics and Organizations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ping Jiang, Doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Jiang, doctor

CONTACT

86010-82266699; jiangping@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share