Using adjuvant chemotherapy for cervical cancer patients with positive HPV DNA in plasma

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 clinical trial evaluates the effectiveness of adjuvant chemotherapy in patients with locally advanced cervical cancer who test positive for cell-free human papillomavirus (cfHPV-DNA) in their plasma after standard treatment. Following a regimen of chemoradiotherapy, patients will undergo testing for cfHPV-DNA, and those who remain positive will be randomized to receive either two additional cycles of chemotherapy or be placed under observation. The study aims to determine if the addition of chemotherapy can improve outcomes for these patients. Participants will be monitored through imaging and clinical examinations every four months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3 to IVA will be included prospectively.
* Previous standard treatment based on concomitant chemoradiotherapy regimen.
* Karnofsky performance status score ≥70, with estimated life expectancy ≥12 weeks,
* Immunocompetent,
* Positive research for types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82 cfHPV-DNA in plasma at the end of chemoradiotherapy,
* Proper hematological, liver and kidney functions. Inclusion criteria will include absolute neutrophils count ≥1.5 x 109/L, platelets ≥100 x 10/L, serum bilirubin ≤ 2.0 x upper limit of normal (ULN), calculated creatinine clearance ≥50 mL/min and alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.
* Patients of child-bearing potential were obligated to use an approved contraceptive method during and for 3 months after the study;
* Agree with research procedures, by signing the Informed Consent Form (ICF).

Exclusion Criteria:

* Previous cervical cancer or other malignancies,
* Pregnant women,
* Inability to perform concurrent cisplatin based-chemoradiotherapy.
* Tumors containing different HPV genotypes
* Absence of anatomopathological examination to prove the diagnosis and/or staging examinations.

Where it's running

• Centro Integrado de Pesquisa da Amazônia, CINPAM
  Manaus, Amazonas, Brazil Recruiting
• Hospital do Câncer de Muriaé
  Muriaé, Minas Gerais, Brazil Recruiting
• Instituto Nacional do Câncer, INCA
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Hospital Unimed
  Joinville, Santa Catarina, Brazil Recruiting
• Hospital da Mulher - SECONCI
  São Paulo, São Paulo, Brazil Recruiting
• Hospital do Coração - Research Institute
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Michelle S Almeida, PhD
• Email: malmeida@hcor.com.br
• Phone: 11 999112805

Similar studies

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

• Short-course (hypofractionated) versus standard radiotherapy with cisplatin and brachytherapy for locally advanced cervical cancer in Uganda

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• Minimally invasive simple hysterectomy for low-risk cervical cancer

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• Combining Pembrolizumab and Lenvatinib for Cervical Cancer Treatment

  This study is testing if a combination of two drugs, pembrolizumab and lenvatinib, can help slow down tumor growth in people with advanced cervical cancer.

  Recruiting Phase 2 University of Texas Southwestern Medical Center · Dallas, Texas · NCT06266338

• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

  This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.

  Recruiting University of California, San Diego · Nairobi · NCT07925307

• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

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  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07904182

• How cinema sessions during chemotherapy might help cervical cancer patients

  We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07902180

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.