A Study of Metformin to Improve Tumour Oxygenation in Cervix Cancer

Official Title

The Potential for Metformin to Improve Tumour Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized Trial

Summary:

Cervical cancer remains an important health problem worldwide. Poor tumour oxygenation (hypoxia) is associated with inferior survival in cervical cancer and resistance to radiation treatment. Hypoxia-modifying therapies improve survival, but existing therapies are impractical and/or toxic. Metformin, a non-toxic drug for diabetes, has been shown to decrease tumour hypoxia in animal studies and its use is associated with better survival in diabetic cancer patients. It is hypothesized that metformin may decrease cervical tumour hypoxia and thereby improve tumour response to radiation and survival in patients with locally advanced cervix cancer. This is a randomized, multicentre phase II study of standard chemoradiation in combination with metformin versus standard chemoradiation alone in women with locally advanced cervix cancer. Women randomized to the metformin group will take metformin starting 1 week prior to standard chemoradiation and throughout the duration of external radiation treatment. Tumour hypoxia will be measured by a special X-ray test called positron emission test (PET) performed with a hypoxia dye called FAZA. The main purpose of this study is to see if metformin decreases tumour hypoxia measured on FAZA-PET; information about response and side effects will also be collected.

Trial Description

Primary Outcome:

  • Change in fractional hypoxic volume from first and second FAZA-PET scan.
Secondary Outcome:
  • Duration of time from randomization to the time of relapse or death
  • Number and types of acute and late gastrointestinal and genitourinary toxicities following metformin and chemoradiation
  • The average difference between the endogenous hypoxia marker levels from the first and second tumour biopsies
  • The average difference between the Ki-67 index from the first and second tumour biopsies

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society