TriangleNCT02466971 · OUTCOME
Progression-free Survival (PFS) Rate at 3 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 3 years from study randomization.
What was measured
Estimate for probability of progression free at 3 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the date of first documented disease recurrence/progression, death from any cause or date of last contact, whichever occurs first. Recurrence is defined as clinical, radiological or histological evidence of recurrent disease post study treatment. Disease progression will be determined from the physical examinations, which were conducted during treatment (day 9, 16, 23, 30 and 37) and follow-up (1 and 3 months after completing protocol therapy, every 3 months for years 1 and 2, and every 6 months for years 3, 4 and 5), and the PET/CT scan conducted 3 months after the end of treatment. Please note that progression defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) is not required by the protocol.
Analysis population: Eligible participants
Groups in this outcome
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV
| Group | Source count |
|---|---|
| Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 224 |
| Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 224 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 69.5 | Not reported | 62 | 76 | Not reported |
| Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 71.4 | Not reported | 64 | 78 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62
- upper Limit
- 76
- value
- 69.5
- group Id
- OG001
- lower Limit
- 64
- upper Limit
- 78
- value
- 71.4
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 224
- units
- Participants
- description
- Estimate for probability of progression free at 3 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the date of first documented disease recurrence/progression, death from any cause or date of last contact, whichever occurs first. Recurrence is defined as clinical, radiological or histological evidence of recurrent disease post study treatment. Disease progression will be determined from the physical examinations, which were conducted during treatment (day 9, 16, 23, 30 and 37) and follow-up (1 and 3 months after completing protocol therapy, every 3 months for years 1 and 2, and every 6 months for years 3, 4 and 5), and the PET/CT scan conducted 3 months after the end of treatment. Please note that progression defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) is not required by the protocol.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT
- id
- OG000
- title
- Arm I (Cisplatin, IMRT or RT, Brachytherapy)
- description
- Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV
- id
- OG001
- title
- Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
- param Type
- NUMBER
- population Description
- Eligible participants
- reporting Status
- POSTED
- time Frame
- At 3 years from study randomization.
- title
- Progression-free Survival (PFS) Rate at 3 Years
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice