Altered Tumor Oxygenation by Metformin a Potential Step in Overcoming Radiotherapy Resistance in LACC

STATUS

Recruiting
participants needed

90
sponsor

Oslo University Hospital

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Updated on 19 February 2024

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cancer

diabetes

blood transfusion

renal function

serum pregnancy test

neutrophil count

squamous cell carcinoma

adenocarcinoma

chemoradiotherapy

carcinoma

hypoxia

metformin

hydronephrosis

renal function test

adenosquamous carcinoma

nephrostomy

cervical neoplasm

cervical cancer

cisplatin

Summary

Poor tumor oxygenation (hypoxia) is an established negative prognostic and predictive factor in locally advanced cervical cancer (LACC). Hypoxia-modifying measures implemented in the clinic are lacking.

Metformin is a well-known, well-tolerated and low-cost drug used for decades in the treatment of type 2- diabetes. Recent studies suggest an improved tumor oxygenation by metformin potentially improving radiotherapy response and patient outcome.

This study is a randomized, phase II, open label study in patients with LACC where patients are randomized to standard cisplatin-based chemoradiotherapy +/- Metformin.

Metformin will be started one week prior to the start of chemoradiotherapy, and will be continued throughout the entire radiation treatment.

Tumor oxygenation will be evaluated by gene signatures and MRI- parameters.

Details

Condition	Cervical Cancer, Cervical Cancer, Uterine Cancer, Uterine Cancer
Age	18-100 years
Treatment	Metformin, Cisplatin
Clinical Study Identifier	NCT04275713
Sponsor	Oslo University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma)
	Planned for radical chemoradiotherapy
	Over 18 years
	Speaks and understands Norwegian
	ECOG 0-1
	Cervical tumor available for biopsy by gynecological examination
	Hemoglobin 9 g/dL (blood transfusions are allowed)
	Leukocytes 3,5 x 10^9/L 18
	Absolute neutrophil count 1,5 x 10^9/L
	Platelets 100 x 10^9/L
	Total bilirubin 25 umol/L
	AST/ALT 2,5 x institutional upper limit
	Creatinine 90 or creatinine clearance 60 ml/min/1.73m2 Patients with elevated creatinine secondary to hydronephrosis may be eligible if renal function returns to normal after inserting an internal stent or nephrostomy
	Women of childbearing potential (WOCBP) should have a negative highly sensitive serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Exclusion Criteria
	Evidence of distant metastasis. Suspicious paraaortic lymph nodes below the renal vessel are allowed if they are covered by the radiation field
	Patients who have received other cancer treatments for their cervical cancer
	Patients who receive other experimental drugs
	Known diabetes mellitus
	Currently taking Metformin or any other antidiabetic drugs (sulfonylureas, thiazolidinediones, insulin)
	History of allergic reaction attributed to compounds of similar chemical or biologic composition to metformin
	Contraindications such as
	Hypersensitivity to the active substance or to any of the excipients listed Section 6.1
	Severe renal failure (GFR <30 ml / min)
	Acute conditions leading to the risk of renal impairment, eg: dehydration, severe infectious conditions, shock
	Disease that can cause tissue hypoxia (especially acute illness or exacerbation of chronic illness), such as: acute decompensated heart failure, lung failure, recent heart attack, shock
	Liver failure, acute alcohol intoxication, alcoholism
	Any condition associated with increased risk of metformin- induced lactic acidosis (congestive heart failure defined as New York Heart Association (NYHA) class III or IV functional status, history of acidosis of any kind)
	Uncontrolled intercurrent somatic illness including, but not limited to, ongoing or active serious infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction within 6 months and cerebrovascular disease with previous stroke
	Already on medication with increased risk of lactic acidosis
	Patients who are pregnant or breastfeeding are excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants

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Altered Tumor Oxygenation by Metformin a Potential Step in Overcoming Radiotherapy Resistance in LACC