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NCT Number: NCT06426056

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: RT

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).

Other names: paclitaxel for injection (albumin bound)

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).

Primary outcomes

  1. ORR (objective response rate)

    Time frame: the 1, 3, 6, 9, 12 months after the end of the treatment

    ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants

Secondary outcomes

  1. AE

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

    adverse events

  2. OS

    Time frame: the 1, 2, and 3 years after the end of the treatment

    objective response rate

  3. PFS

    Time frame: the 1, 2, and 3 years after the end of the treatment

    progression-free survival

  4. DOR

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

    duration of response

  5. DCR

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

    disease control rate

  6. CBR

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

    clinical benefit rate

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Jiang, doctor

CONTACT

[email protected]

86010-82266699

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Affiliated Hospital of Hebei University
  • Hebei Medical University Fourth Hospital
  • Jilin Provincial Tumor Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
May 23, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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