Chemotherapy and radiation treatment for cervical cancer

Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients

This study is testing whether combining a new type of radiation with chemotherapy is safe and effective for women with stage III cervical cancer compared to standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: National Institute of Cancerología (other gov)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Mexico City, Tlalpan)
• Trial ID: NCT04070976 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the safety and effectiveness of combining chemotherapy with external hypofractionated radiation therapy, followed by brachytherapy, in women with clinical stage III cervical cancer. Participants will be randomly assigned to receive either standard fractionated radiation or hypofractionated radiation alongside chemotherapy. The study will assess various outcomes, including safety profiles, survival rates, quality of life, and treatment costs. The data collected will help determine the impact of hypofractionated radiation therapy on patient health and treatment experiences.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old with clinical stage III cervical cancer and no prior treatment.

Not a fit: Patients with distant metastases or those who have received previous treatment for cervical cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with advanced cervical cancer.

How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy, suggesting potential benefits in similar patient populations.

Eligibility criteria

Inclusion Criteria:

* Women over 18 years old
* Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages
* Histology: squamous, adenosquamous or adenocarcinoma
* No previous treatment
* No distance metastases, discard by Positron Emission Tomography (PET)/CT
* Functional State ECOG (Eastern Cooperative Oncology Group) 0-2
* Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:
* Absolute neutrophil count ≥ 1,500 cell/mm3
* Platelets ≥ 100,000 cell/mm3
* Hemoglobin ≥ 10.0 g/dl
* Leukocyte count ≥ 4000 cell/mm3
* Adequate Renal Function defined as:
* Serum Creatinine ≤ 1.5 mg/dl within 14 days before admission to the study
* Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count ≥ 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)
* The patient must understand the protocol and provide the specific informed consent of the study before admission
* Negative pregnancy test

Exclusion Criteria:

* Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
* Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)
* Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years
* Severe active or non-controlled co-morbidities, defined as:
* Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.
* Transmural myocardial infarction in the last 6 months.
* Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.
* Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.
* Crohn's disease or ulcerative colitis.
* Prior allergic reaction to cisplatin or other drugs based on platinum.
* Other factors that contraindicate experimental therapy.

Where this trial is running

Mexico City, Tlalpan

• David Cantu de Leon — Mexico City, Tlalpan, Mexico (RECRUITING)

Study contacts

• Principal investigator: David F Cantú-deLeón — Instituto Nacional de Cancerologia de Mexico
• Study coordinator: David F Cantú-de León, Md, MSc. PhD

Conditions: Cervical Cancer, hypofractionated radiotherapy, Brachytherapy