Treatment for locally advanced cervical cancer using hypofractionated radiation and chemotherapy

Phase II Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With Standard Fractionated Compared to Hypofractionated Followed by Surgery for Patients With Locally Advanced Cervical Cancer.

This study is testing if a new type of radiation therapy combined with chemotherapy can treat locally advanced cervical cancer better and with fewer side effects than standard radiation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: National Institute of Cancerología (Government)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Mexico City, Tlalpan and 1 other locations)
• Trial ID: NCT03750539 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of hypofractionated radiation therapy combined with chemotherapy in treating locally advanced cervical cancer. Patients will be randomly assigned to receive either standard radiation or hypofractionated radiation, followed by surgery. The study will assess various toxicities, particularly gastrointestinal, and will monitor quality of life over time. The aim is to determine if hypofractionated radiation can provide a safer treatment option with fewer side effects.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with FIGO stage IB2-IIB cervical cancer without distant metastasis.

Not a fit: Patients with advanced disease outside the pelvis or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced toxicity for patients with cervical cancer.

How similar studies have performed: While the approach of hypofractionated radiation is gaining interest, this specific study's methodology is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

* Patients must have International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IIB squamous, adenosquamous or adenocarcinoma of cervical with no disease outside of the pelvis by via ultrasound.
* No distant metastasis via chest X-ray.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Age 18
* complete blood count (CBC)/differential obtained 14 days before study entry with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mim3
* Platelets 100,000 cells/mim3
* Hemoglobin 8.0 g/dl
* White blood count 4000 cell/m3
* An adequate renal function defined as follows:
* Serum creatinine 1.5 mg/dl within 14 days before study entry
* Patients with known HIV positive must have a cluster of differentiation 4 (CD4) T lymphocytes count be 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol). Excluding HIV positive patients with invasive cervical cancer and low CD4 cell counts is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
* Chest x-ray and ultrasound must be performed within 12 (8 or 12) weeks before the study enrollment (I took out the ct scan of abdomen and pelvis)
* Patient must provide study-specific informed consent before study entry.

Exclusion Criteria:

* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast or oral cavity.
* Patients cannot have any neuroendocrine histology in pathology.
* Prior systemic chemotherapy for the current cervical cancer, note that prior chemotherapy for a different cancer is allowable.
* Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields.
* Severe active co-morbidity, defined as follows:
* Unstable angina or congestive heart failure requiring hospitalization within the last six months.
* Transmural myocardial infarction within the previous six months.
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of the study entry.
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry.
* Coagulation defects; note, however, that coagulation parameter are not required for entry into this protocol.
* Prior allergic reaction to cisplatin or other platinum drugs.
* Patients with para-aortic nodes or distant metastasis.

Where this trial is running

Mexico City, Tlalpan and 1 other locations

• David Cantu de Leon — Mexico City, Tlalpan, Mexico (Active_not_recruiting)
• Instituto Nacional de Cancerologia — Mexico City, Mexico (Recruiting)

Study contacts

• Principal investigator: David F Cantu-de Leon, MD, Msc, PhD — Instituto Nacional de Cancerologia, Columbia
• Study coordinator: David F Cantu-de Leon, MD, MSC, PhD

Conditions Cervix Cancer