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

NCT04275713 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-01-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metformin

Metformin is an oral antidiabetic drug

DRUG

Cisplatin

Cisplatin 40 mg/m2 given intravenously once a week, maximum 6 cycles

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Kjersti Bruheim, PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2024-06-11
Completion
2024-11-08

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04275713 on ClinicalTrials.gov