TriangleNCT01167712 · STUDY IN CONTEXT
Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product
First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
First Quartile Overall Survival
Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)
Reported safety
Quality of life and patient-reported measures
FACT · Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- qol key
- qol-0002
- source section id
- NCT01167712-om-0002
- source outcome index
- 2
- instrument
- FACT
- instrument basis
- matched 'fact-o' in the study's own wording
- scale title
- Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)
- measure definition
- Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)
- time frame
- 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- trial label
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 4
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0003
- source section id
- NCT01167712-om-0003
- source outcome index
- 3
- endpoint
- Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product
- endpoint definition
- Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product
- time origin
- Baseline (T0) up to 10 days after the start of course 2 (T2)
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0000
- source section id
- NCT01167712-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival
- endpoint definition
- First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- time origin
- The timeframe is from enrollment onto the study up to 3 years following enrollment.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Whole sample
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0001
- source section id
- NCT01167712-om-0001
- source outcome index
- 1
- endpoint
- Median Duration of First Quartile Survival
- endpoint definition
- First Quartile Overall Survival
- time origin
- The timeframe is from enrollment onto the study up to 3 years after enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Whole sample
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0002
- source section id
- NCT01167712-om-0002
- source outcome index
- 2
- endpoint
- Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)
- endpoint definition
- Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)
- time origin
- 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
- regimen
- Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV
- analyzed count
- 346
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01167712-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Neoadjuvant Chemotherapy)
- regimen
- Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
- analyzed count
- 346
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01167712-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
- regimen
- Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV
- analyzed count
- 346
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01167712-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Neoadjuvant Chemotherapy)
- regimen
- Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
- analyzed count
- 346
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01167712-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
- regimen
- Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV
- analyzed count
- 292
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01167712-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (Neoadjuvant Chemotherapy)
- regimen
- Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
- analyzed count
- 287
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01167712-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- harm key
- EG000
- source section id
- NCT01167712-ae
- event group key
- EG000
- event group label
- Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
- serious affected
- 122
- serious at risk
- 346
- other affected
- 343
- other at risk
- 346
- frequency threshold
- 0
- collection period
- AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- harm key
- EG001
- source section id
- NCT01167712-ae
- event group key
- EG001
- event group label
- Arm II (Neoadjuvant Chemotherapy)
- serious affected
- 167
- serious at risk
- 346
- other affected
- 340
- other at risk
- 346
- frequency threshold
- 0
- collection period
- AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm-cisplatin-6f0c5203
- nct id
- NCT01167712
- qol key
- qol-0002
- source section id
- NCT01167712-om-0002
- source outcome index
- 2
- instrument
- FACT
- instrument basis
- matched 'fact-o' in the study's own wording
- scale title
- Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)
- measure definition
- Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)
- time frame
- 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice