TriangleNCT00006436 · OUTCOME
Overall Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- The participants were followed for an average of 6 months to determine response to therapy.
What was measured
Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month.
Analysis population: One participant declined to participate before treatment started, and one participant was not evaluable.
Groups in this outcome
Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
| Group | Source count |
|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 66 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 53 | Not reported | Not reported | Not reported | Not reported |
Complete Response Unconfirmed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 10 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
Non-Responder - Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
Non-Responder - Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 53
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- Complete Response Unconfirmed
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Non-Responder - Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Non-Responder - Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 66
- units
- Participants
- description
- Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month.
- groups
- description
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- id
- OG000
- title
- Arm 1-Combination Chemo and Biological Therapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One participant declined to participate before treatment started, and one participant was not evaluable.
- reporting Status
- POSTED
- time Frame
- The participants were followed for an average of 6 months to determine response to therapy.
- title
- Overall Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice