Cervical CancerPhase 2NCT06353061
Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer
A Phase 2 study testing Metformin, Radiotherapy and Chemotherapy in people with Cervical Cancer and Radiotherapy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Radiotherapy, Metformin
- What is being tested?
- Metformin, Radiotherapy and Chemotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 1 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70 years old
- Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- FIGO stage IB2-IVA
- Baseline CT or MRI indicating tumor necrosis (clinical hypoxia)
- Hemoglobin ≥90g/L (blood transfusions allowed); no prior chemotherapy
- ECOG performance status 0-2
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- No severe hematopoietic dysfunction, and no significant cardiac, pulmonary, hepatic, renal dysfunction, or immune deficiency
- Able to undergo PET/CT imaging
- Feasible for gynecological examination and cervical biopsy
- Not pregnant or breastfeeding
Who cannot join
- 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.
- Diagnosed diabetes mellitus or current use of metformin or any other antidiabetic medication.
- 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%.
- Serum transaminases exceeding 3 times the upper limit of normal, liver failure, alcohol poisoning.
- History of allergic reactions to compounds chemically or biologically similar to metformin.
- Concurrent hypoglycemia, such as insulinoma, autoimmune hypoglycemia, or functional hypoglycemia, or fasting blood glucose persistently less than 2.8 mmol/L before enrollment.
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- Malnutrition, BMI <18.5.
- Concurrent unhealed gastric ulcer, duodenal ulcer, ulcerative colitis, Crohn's disease, or recent episodes of severe abdominal pain, diarrhea, vomiting, etc.
- Concurrent rectovaginal fistula, vesicovaginal fistula, uncontrolled vaginal bleeding, or those at risk of fistula.
- Inability to undergo intracavitary radiotherapy as assessed by the investigator.
- Human immunodeficiency virus (HIV) infection.
- Severe underlying diseases that are untreatable.
- History of other malignant tumors (excluding cured basal cell carcinoma of the skin) or previous pelvic radiotherapy.
- Currently participating in other clinical trials or stopped participating in clinical trials less than 4 weeks ago.
- Neurological or psychiatric abnormalities affecting cognitive function.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 310013
xiaorong hou, Dr, +8618810679890, kangren2021@126.com
About this study
Official title: Phase II Randomized Window of Opportunity Trial of Chemoradiotherapy Alone Versus Combination With Metformin in Locally Advanced Cervical Cancer
This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients.
- Conditions
- Cervical Cancer, Radiotherapy, Metformin, Hypoxia, PET/CT
- Being tested
- Metformin, Radiotherapy, Chemotherapy, PET/CT
- Keywords
- Cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Patients randomized to the metformin group will start taking metformin within 1 day after group allocation. They will take one tablet of metformin (850 mg) once daily for three consecutive days. Subsequently, they will take metformin orally twice daily throughout the entire external and internal irradiation period, with each administration consisting of one tablet.
RadiotherapyRadiation
The study requires all subjects to sequentially undergo external beam radiotherapy (EBRT) and intracavitary brachytherapy (BT). All radiotherapy must be completed within 7-8 weeks after treatment initiation. The total prescribed dose EQD2 for EBRT combined with BT should be ≥80 Gy; for subjects with squamous carcinoma with lesions ≤4 cm, the HR-CTV D90 should be ≥80 Gy; for subjects with adenocarcinoma or lesions >4 cm, it is recommended that HR-CTV D90 should be ≥85 Gy. When the prescribed dose is limited by organs at risk (OAR), priority should be given to covering HR-CTV. The radiotherapy plan in this study is based on image guidance. Imaging scans can use MRI or CT, and the scanning area should extend at least 5 cm above and below the PTV.
ChemotherapyDrug
The dosage of cisplatin is 40 mg/m2, administered once weekly during radiotherapy for a duration of 5 weeks. Prior to and following cisplatin administration, 1-2 liters of fluid should be given for adequate hydration. Treatment should continue until disease progression or intolerable toxicity occurs.
PET/CTDiagnostic test
Using 68Ga-NY104 as a small molecule targeted imaging agent for CA-IX, two CA-IX PET/CT scans will be conducted in patients: one upon enrollment and another one week after randomization.
| Study group | Role | What they receive |
|---|---|---|
| The group treated with metformin in combination with synchronous chemoradiotherapy | Experimental | After the group allocation is determined, patients in the experimental group will undergo CA-IX PET/CT scans. Subsequently, they will commence taking metformin at a dose of 850 mg per tablet, once daily, for three consecutive days. One week later, a second CA-IX PET/CT scan will be performed. Following this, synchronous chemoradiotherapy will be initiated, with patients taking metformin twice daily during the course of radiotherapy, at a dosage of one tablet per administration. Receives: Drug: Metformin; Radiation: Radiotherapy; Drug: Chemotherapy; Diagnostic Test: PET/CT |
| The group undergoing chemoradiotherapy alone. | Active comparator | Patients in the control group will undergo the first CA-IX PET/CT scan after the group allocation. One week later, they will undergo the second PET/CT scan. Subsequently, they will commence synchronous chemoradiotherapy. Receives: Radiation: Radiotherapy; Drug: Chemotherapy; Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree to which metformin improves the hypoxic index measured by CAIX PET
Using the uptake value parameter of CA-IX in PET/CT, comparing the changes in uptake values between the two scans as an indicator of improvement in hypoxia level
Measured: 1week after randomization
Secondary outcomes (4)
Progression-free survival（PFS）
Progression-free survival is defined as the time from randomization to disease progression or death from any cause,whichever is first.
Measured: 2-year
Changes in tumor volume during treatment
Tumor volume will be measured via pelvic MRI.
Measured: Baseline，1month and 2 months.
Hematologic and gastrointestinal toxicities assessed by CTCAE v5.0
Treatment-related toxicity reactions in both groups of patients will be evaluated during the treatment period, at the end of treatment, and three months after treatment completion
Measured: Up to 3 months after treatment.
Quality of life assessed by QLQ-C30
Assessment of quality of life in both groups of patients
Measured: Up to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start15 Apr 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353061
- Sponsor's protocol ID
- LACC-MET
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Window of Opportunity Trial of Chemoradiotherapy Alone Versus Combination With Metformin in Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT06353061
- Acronym / sponsor ID
- LACC-MET
- Conditions
- Cervical Cancer, Radiotherapy, Metformin, Hypoxia, PET/CT
- Keywords
- Cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group treated with metformin in combination with synchronous chemoradiotherapy | Experimental | Drug: Metformin, Radiation: Radiotherapy, Drug: Chemotherapy, Diagnostic Test: PET/CTAfter the group allocation is determined, patients in the experimental group will undergo CA-IX PET/CT scans. Subsequently, they will commence taking metformin at a dose of 850 mg per tablet, once daily, for three consecutive days. One week later, a second CA-IX PET/CT scan will be performed. Following this, synchronous chemoradiotherapy will be initiated, with patients taking metformin twice daily during the course of radiotherapy, at a dosage of one tablet per administration. |
| The group undergoing chemoradiotherapy alone. | Active comparator | Radiation: Radiotherapy, Drug: Chemotherapy, Diagnostic Test: PET/CTPatients in the control group will undergo the first CA-IX PET/CT scan after the group allocation. One week later, they will undergo the second PET/CT scan. Subsequently, they will commence synchronous chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ages 18-70 years old
- Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- FIGO stage IB2-IVA
- Baseline CT or MRI indicating tumor necrosis (clinical hypoxia)
- Hemoglobin ≥90g/L (blood transfusions allowed); no prior chemotherapy
Key exclusion criteria (15 listed)
- 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.
- Diagnosed diabetes mellitus or current use of metformin or any other antidiabetic medication.
- 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%.
- Serum transaminases exceeding 3 times the upper limit of normal, liver failure, alcohol poisoning.
- History of allergic reactions to compounds chemically or biologically similar to metformin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminPatients randomized to the metformin group will start taking metformin within 1 day after group allocation. They will take one tablet of metformin (850 mg) once daily for three consecutive days. Subsequently, they will take metformin orally twice daily throughout the entire external and internal irradiation period, with each administration consisting of one tablet. | Drug | The group treated with metformin in combination with synchronous chemoradiotherapy |
| RadiotherapyThe study requires all subjects to sequentially undergo external beam radiotherapy (EBRT) and intracavitary brachytherapy (BT). All radiotherapy must be completed within 7-8 weeks after treatment initiation. The total prescribed dose EQD2 for EBRT combined with BT should be ≥80 Gy; for subjects with squamous carcinoma with lesions ≤4 cm, the HR-CTV D90 should be ≥80 Gy; for subjects with adenocarcinoma or lesions >4 cm, it is recommended that HR-CTV D90 should be ≥85 Gy. When the prescribed dose is limited by organs at risk (OAR), priority should be given to covering HR-CTV. The radiotherapy plan in this study is based on image guidance. Imaging scans can use MRI or CT, and the scanning area should extend at least 5 cm above and below the PTV. | Radiation | The group treated with metformin in combination with synchronous chemoradiotherapy, The group undergoing chemoradiotherapy alone. |
| ChemotherapyThe dosage of cisplatin is 40 mg/m2, administered once weekly during radiotherapy for a duration of 5 weeks. Prior to and following cisplatin administration, 1-2 liters of fluid should be given for adequate hydration. Treatment should continue until disease progression or intolerable toxicity occurs. | Drug | The group treated with metformin in combination with synchronous chemoradiotherapy, The group undergoing chemoradiotherapy alone. |
| PET/CTUsing 68Ga-NY104 as a small molecule targeted imaging agent for CA-IX, two CA-IX PET/CT scans will be conducted in patients: one upon enrollment and another one week after randomization. | Diagnostic test | The group treated with metformin in combination with synchronous chemoradiotherapy, The group undergoing chemoradiotherapy alone. |
Primary outcome
The degree to which metformin improves the hypoxic index measured by CAIX PET
Time frame: 1week after randomization
Using the uptake value parameter of CA-IX in PET/CT, comparing the changes in uptake values between the two scans as an indicator of improvement in hypoxia level
4 secondary outcomes
Progression-free survival（PFS）
Time frame: 2-year
Changes in tumor volume during treatment
Time frame: Baseline，1month and 2 months.
Hematologic and gastrointestinal toxicities assessed by CTCAE v5.0
Time frame: Up to 3 months after treatment.
Quality of life assessed by QLQ-C30
Time frame: Up to 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin, Radiotherapy and Chemotherapy in people with Cervical Cancer and Radiotherapy, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kang ren, PhD (+86-18810679890, kangren2021@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree to which metformin improves the hypoxic index measured by CAIX PET (time frame: 1week after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.