Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Apr 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether adding metformin, a medication commonly used for diabetes, can help improve treatment outcomes for women with locally advanced cervical cancer. The researchers believe that metformin may help reduce a condition called hypoxia, where the tumor doesn't get enough oxygen, potentially leading to better results after treatment. In this study, participants will receive standard chemoradiotherapy, which combines chemotherapy and radiation, either with or without metformin. Researchers will use advanced imaging techniques to check the levels of hypoxia in the tumors and see how it affects survival without disease progression.

To be eligible for this trial, participants need to be women aged 18 to 70 with specific types of cervical cancer and a certain stage of the disease. They should also have some signs of tumor necrosis, or clinical hypoxia, but cannot have diabetes or be using antidiabetic medications like metformin. Participants will undergo regular check-ups, including imaging tests, and will be closely monitored throughout the study to assess their health and treatment response. If you or someone you know meets these criteria and is interested in participating, it could be a valuable opportunity to contribute to important cancer research.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 18-70 years old
• • 2. Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
• • 3. FIGO stage IB2-IVA
• • 4. Baseline CT or MRI indicating tumor necrosis (clinical hypoxia)
• • 5. Hemoglobin ≥90g/L (blood transfusions allowed); no prior chemotherapy
• • 6. ECOG performance status 0-2
• • 7. No severe hematopoietic dysfunction, and no significant cardiac, pulmonary, hepatic, renal dysfunction, or immune deficiency
• • 8. Able to undergo PET/CT imaging
• • 9. Feasible for gynecological examination and cervical biopsy
• • 10. Not pregnant or breastfeeding
• Exclusion Criteria:
• • 1. Renal insufficiency with eGFR \<45 ml‧min-1‧1.73 m-2, and acute conditions that may lead to renal impairment such as dehydration, severe infectious diseases, shock, etc.
• • 2. Diagnosed diabetes mellitus or current use of metformin or any other antidiabetic medication.
• • 3. Concurrent diseases that may lead to tissue hypoxia (especially acute or exacerbated chronic conditions), such as acute heart failure, pulmonary fibrosis, respiratory failure, recent myocardial infarction, or blood pressure monitoring showing less than 90/60 mmHg, SpO2 \<90%.
• • 4. Serum transaminases exceeding 3 times the upper limit of normal, liver failure, alcohol poisoning.
• • 5. History of allergic reactions to compounds chemically or biologically similar to metformin.
• • 6. Concurrent hypoglycemia, such as insulinoma, autoimmune hypoglycemia, or functional hypoglycemia, or fasting blood glucose persistently less than 2.8 mmol/L before enrollment.
• • 7. Malnutrition, BMI \<18.5.
• • 8. Concurrent unhealed gastric ulcer, duodenal ulcer, ulcerative colitis, Crohn's disease, or recent episodes of severe abdominal pain, diarrhea, vomiting, etc.
• • 9. Concurrent rectovaginal fistula, vesicovaginal fistula, uncontrolled vaginal bleeding, or those at risk of fistula.
• • 10. Inability to undergo intracavitary radiotherapy as assessed by the investigator.
• • 11. Human immunodeficiency virus (HIV) infection.
• • 12. Severe underlying diseases that are untreatable.
• • 13. History of other malignant tumors (excluding cured basal cell carcinoma of the skin) or previous pelvic radiotherapy.
• • 14. Currently participating in other clinical trials or stopped participating in clinical trials less than 4 weeks ago.
• • 15. Neurological or psychiatric abnormalities affecting cognitive function.