New treatment approach for locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a new treatment method for locally advanced cervical cancer that combines upfront brachytherapy with hypofractionated external beam radiation and chemotherapy. The goal is to reduce overall treatment time, which is crucial for improving patient outcomes. The study will assess the impact of this approach on late gastrointestinal and genitourinary toxicity, recurrence-free survival, and the immune response in patients. It targets patients with specific stages of cervical cancer to determine the feasibility and effectiveness of this treatment strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Newly diagnosed biopsy proven FIGO (2018) clinical stage IB3-IVA cervical carcinoma.
* Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
* Candidate for definitive radiation therapy as determined by treating radiation oncologist.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representative may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

* Any prior pelvic radiotherapy.
* Any prior gynecologic or other pelvic malignancy.
* Any prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for the trial.
* Evidence of metastatic disease outside of the pelvis or para-aortic nodes.
* Previous hysterectomy or planned hysterectomy as part of initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test day of or within 7 days prior to simulation.
* Major surgery ≤ 3 weeks prior to initiating protocol therapy; if a patient has had major surgery prior to 3 weeks, they must have recovered from any surgical effects.
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Stephanie Markovina, M.D. — Washington University School of Medicine
• Study coordinator: Stephanie Markovina, M.D.
• Email: smarkovina@wustl.edu
• Phone: 314-747-1786

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cadonilimab with chemotherapy followed by concurrent chemoradiotherapy for locally advanced cervical cancer

  This phase 3 study will test whether adding cadonilimab to initial chemotherapy and then giving standard concurrent chemoradiotherapy helps women aged 18–70 with stage IIB–IVA locally advanced cervical cancer have better tumor responses and outcomes than standard chemoradiotherapy alone.

  Recruiting Phase 3 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07400536

• Ultraaccelerated high-dose-rate intrauterine brachytherapy for locally advanced cervical cancer

  This project tests a faster, higher-dose internal radiation (brachytherapy) after chemoradiation to see if bowel, bladder, vaginal, and sexual side effects are acceptable for people with locally advanced cervical cancer.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome · NCT06398938

• Treatment for advanced cervical cancer using chemoradiotherapy and immunotherapy

  This study is testing a new treatment combining chemotherapy and immunotherapy to see if it helps people with advanced cervical cancer feel better and live longer.

  Recruiting Phase 1/2 RenJi Hospital · Shanghai · NCT06391190

• Assessing the effects of radiotherapy on tumors in cervical and pancreatic cancer

  This study is testing how radiotherapy affects tumors in patients with locally advanced cervical and pancreatic cancer by collecting samples and using special imaging before, during, and after treatment.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT05975593

• Adaptive Proton Therapy for Cervical Cancer

  This study is testing if a new type of radiation therapy called intensity modulated proton therapy can help women with advanced cervical cancer have fewer side effects and better outcomes compared to standard radiation treatments.

  Recruiting Leiden University Medical Center · Leiden and 1 other locations · NCT05406856

• Personalized vaccine combined with pembrolizumab for advanced solid tumors

  This study is testing a new personalized cancer vaccine combined with pembrolizumab to see if it helps people with advanced solid tumors fight their cancer better.

  Recruiting Phase 1/2 Mayo Clinic · Jacksonville, Florida · NCT05269381

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.