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NCT06426056Not yet recruitingPhase 2

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.

Source: ClinicalTrials.gov · Last updated 23 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
64 (estimated)
First submitted
17 May 2024
Start date
Jun 2024
Primary completion date
Sept 2025
Lead sponsor
Peking University Third Hospital
NCT number
NCT06426056

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 64
  • From Jun 2024 to the primary completion date, Sept 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • (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;
  • (6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ;
  • (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;

Other illness

  • (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;
  • (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;
  • (11) Human immunodeficiency virus (HIV) positive individuals;
  • (12) Uncontrolled or active viral hepatitis or infection with human immunodeficiency virus;

Lab values

  • (1) Individuals who have previously received chemotherapy with albumin bound paclitaxel;

Other

  • (13) Researchers determine that it is not suitable to participate in this study.

Who the study is looking for

  • (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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.