TriangleNCT02595879 · OUTCOME
Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage response-evaluable patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 3 months post-treatment
What was measured
The mCR rate at recommended phase 2 dose, defined as a metabolic complete response on PET/CT will be defined as greater than -66% reduction in tumor FDG uptake at sites of abnormal tumor FDG uptake noted on pre-treatment FDG-PET study (considering normal cardiac or liver blood pool).
Analysis population: Patients who received at least 3 weeks of therapy (cisplatin + triapine), and had their disease re-evaluated with a 3-month post treatment 18F-FDG-PET/CT
Groups in this outcome
Triapine (100mg) + Chemoradiation)
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
Triapine (150mg) + Chemoradiation)
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
| Group | Source count |
|---|---|
| Triapine (100mg) + Chemoradiation) | 13 |
| Triapine (150mg) + Chemoradiation) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Triapine (100mg) + Chemoradiation) | 62 | Not reported | 30 | 86 | Not reported |
| Triapine (150mg) + Chemoradiation) | 100 | Not reported | 32 | 100 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30
- upper Limit
- 86
- value
- 62
- group Id
- OG001
- lower Limit
- 32
- upper Limit
- 100
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- The mCR rate at recommended phase 2 dose, defined as a metabolic complete response on PET/CT will be defined as greater than -66% reduction in tumor FDG uptake at sites of abnormal tumor FDG uptake noted on pre-treatment FDG-PET study (considering normal cardiac or liver blood pool).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
- id
- OG000
- title
- Triapine (100mg) + Chemoradiation)
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
- id
- OG001
- title
- Triapine (150mg) + Chemoradiation)
- param Type
- NUMBER
- population Description
- Patients who received at least 3 weeks of therapy (cisplatin + triapine), and had their disease re-evaluated with a 3-month post treatment 18F-FDG-PET/CT
- reporting Status
- POSTED
- time Frame
- At 3 months post-treatment
- title
- Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate
- type
- SECONDARY
- unit Of Measure
- percentage response-evaluable patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice