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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00287 | Registry Identifier | NCI CTRP |
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Poor Accrual
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The goal of this clinical research study is to learn if giving metformin in combination with radiation therapy is more effective than radiation therapy alone. In this study, participants will receive either metformin or a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
This is an investigational study. Metformin is FDA approved for the treatment of diabetes. Its use in this study to be given with radiation therapy to treat lung cancer is investigational. The study doctor can explain how the study drug is designed to work.
Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body Radiotherapy (SBRT) + Metformin | Experimental | Participants randomized to Metformin treatment receive Metformin for 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Metformin administered at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week. SBRTdelivered per standard of care practice. |
|
| Stereotactic Body Radiotherapy (SBRT) + Placebo | Placebo Comparator | Participants randomized to placebo treatment 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day. SBRT delivered per standard of care practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin treatment given at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| RECIST and PERCIST Tumor Response | The primary objective is the effect of metformin on response in NSCLC patients treated with hypofractionated RT. All patients will receive FDG-PET/CT scan at baseline (prior to metformin start), prior to RT and at 6 months (+/- 30 days) following RT. PET/CT imaging using [18F]-2-fluoro-2-deoxyglucose positron emission tomography (18F-FDG), using a standard approved radiopharmaceutical dose and administration selected by the nuclear medicine physician (120 min). Response will be determined at 6 months post-treatment via relative change from pre-treatment tumor by Response Evaluation Criteria in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR). | From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen G. Chun, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31990759 | Derived | Chun SG, Liao Z, Jeter MD, Chang JY, Lin SH, Komaki RU, Guerrero TM, Mayo RC, Korah BM, Koshy SM, Heymach JV, Koong AC, Skinner HD. Metabolic Responses to Metformin in Inoperable Early-stage Non-Small Cell Lung Cancer Treated With Stereotactic Radiotherapy: Results of a Randomized Phase II Clinical Trial. Am J Clin Oncol. 2020 Apr;43(4):231-235. doi: 10.1097/COC.0000000000000632. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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A total of 27 patients were consented to this study, but 9 patients withdrew consent prior to protocol medication or treatment. 18 patients randomized and treated under this protocol.
A total of 18 lung non-small cell lung cancer (NSCLC) patients were consented and randomized. Eligible criteria: pathologic diagnosis of AJCC Stage I-II, cT1-T2N0M0, can be treated with hypofractionated radiotherapy, not a surgical candidate, have adequate renal function within 30 days prior to registration, and plans to receive treatment at MDACC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin Arm | Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin. |
| FG001 | Placebo Arm | Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 18 stage I non-small cell lung cancer (NSCLC) patients were consented and randomized. Metformin Arm 16 patients and Placebo Arm 2 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin Arm | Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin. |
| BG001 | Placebo Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RECIST and PERCIST Tumor Response | The primary objective is the effect of metformin on response in NSCLC patients treated with hypofractionated RT. All patients will receive FDG-PET/CT scan at baseline (prior to metformin start), prior to RT and at 6 months (+/- 30 days) following RT. PET/CT imaging using [18F]-2-fluoro-2-deoxyglucose positron emission tomography (18F-FDG), using a standard approved radiopharmaceutical dose and administration selected by the nuclear medicine physician (120 min). Response will be determined at 6 months post-treatment via relative change from pre-treatment tumor by Response Evaluation Criteria in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR). | Three participants did not complete the treatment ( Metformin Arm in 2 and Placebo Arm in 1). 15 participants randomized and completed ( Placebo Arm in 1 and Metformin Arm in 14). One participant died prior post treatment 6 months evaluation. | Posted | Count of Participants | Participants | From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months |
From the time of registration through study completion and follow up, assessed up to 6 months
Adverse Events report based on Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE 4.0). All in the study patient encounter or treatment areas should have access to a copy of these criteria from the start of protocol treatment. Attributable to the protocol treatment (definitely, probably, or possibly related) should be reported as well.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin Arm | Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Chun/Assistant Professor, Radiation Oncology | UT MD Anderson Cancer Center | 713- 563-9600 | sgchun@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2017 | Oct 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2017 | Oct 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000073893 | Sugars |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D002241 |
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|
| Placebo | Other | Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day. |
|
|
| Stereotactic body Radiotherapy (SBRT) | Radiation | SBRT delivered per standard of care practice as determined by participant's physician. |
|
|
Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total 15 patients completed treatment under the protocol and evaluable for data analysis. | Three patients can not complete the treatment ( Metformin Arm in 2 and Placebo Arm in 1). There were 15 patients completed treatment. Randomized to placebo in 1 and to metformin in 14. American Joint Committee on Cancer [AJCC] 7th Ed: Stage IA: T1a, b N0 M0 Stage IB: T2a N0 M0 , T1a: primary tumor ≤2 cm, T1b: primary tumor >2-3 cm, T2a: primary tumor >3-5 cm, The earlier TNM staging, the better treatment outcome | Number | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Metformin Arm | Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin. |
| OG001 | Placebo Arm | Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo. |
|
|
| 1 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo Arm | Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Carbohydrates |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |