NCT02101788 · STUDY IN CONTEXT

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.

All randomized patients

→

secondary · POSTED

Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.

Treated with randomized therapy

→

secondary · POSTED

Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.

All randomized patients

→

secondary · POSTED

The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.

Randomized patients

→

secondary · POSTED

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition

Patients who provided baseline and ≥ 1 follow-up assessment

→

secondary · POSTED

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms

Patients that provided baseline and ≥ 1 follow-up assessment

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Patients Reported Acute Quality of Life

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-micropapillary-serous-carcinoma
nct id: NCT02101788
qol key: qol-0004
source section id: NCT02101788-om-0004
source outcome index: 4
instrument: FACT
instrument basis: matched 'fact-o' in the study's own wording
scale title: Patients Reported Acute Quality of Life
measure definition: Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
time frame: 1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Patients who provided baseline and ≥ 1 follow-up assessment
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Patient Reported Acute Peripheral Neuropathy Symptoms

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-micropapillary-serous-carcinoma
nct id: NCT02101788
qol key: qol-0005
source section id: NCT02101788-om-0005
source outcome index: 5
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Patient Reported Acute Peripheral Neuropathy Symptoms
measure definition: Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
time frame: Up to 52 weeks
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Patients that provided baseline and ≥ 1 follow-up assessment
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-micropapillary-serous-carcinoma
nct id: NCT02101788
trial label: Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 3
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0000
source section id
NCT02101788-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS)
endpoint definition
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.
time origin
Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients
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-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0001
source section id
NCT02101788-om-0001
source outcome index
1
endpoint
Incidence of Adverse Events (AEs)
endpoint definition
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.
time origin
During treatment period and up to 100 days after stopping the study treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Treated with randomized therapy
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-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0002
source section id
NCT02101788-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.
time origin
Time from study entry to time of death or date of last contact, an average of 29 months for arm A and 37 months for arm B
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients
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-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0003
source section id
NCT02101788-om-0003
source outcome index
3
endpoint
Objective Tumor Response Rate (Complete Response and Partial Response)
endpoint definition
The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.
time origin
Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Randomized patients
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-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0004
source section id
NCT02101788-om-0004
source outcome index
4
endpoint
Patients Reported Acute Quality of Life
endpoint definition
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
time origin
1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who provided baseline and ≥ 1 follow-up assessment
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-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0005
source section id
NCT02101788-om-0005
source outcome index
5
endpoint
Patient Reported Acute Peripheral Neuropathy Symptoms
endpoint definition
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
time origin
Up to 52 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients that provided baseline and ≥ 1 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-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0000
arm key
OG000
arm label
Arm A - Control Arm
regimen
Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
analyzed count
130
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0000
arm key
OG001
arm label
Arm B - Experimental Arm
regimen
Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
analyzed count
130
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0001
arm key
OG000
arm label
Arm A - Control Arm
regimen
Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
analyzed count
127
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0001
arm key
OG001
arm label
Arm B - Experimental Arm
regimen
Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
analyzed count
127
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0002
arm key
OG000
arm label
Arm A - Control Arm
regimen
Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
analyzed count
130
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0002
arm key
OG001
arm label
Arm B - Experimental Arm
regimen
Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
analyzed count
130
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0003
arm key
OG000
arm label
Arm A - Control Arm
regimen
Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
analyzed count
130
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0003
arm key
OG001
arm label
Arm B - Experimental Arm
regimen
Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
analyzed count
130
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0004
arm key
OG000
arm label
Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
regimen
Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
analyzed count
98
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0004
arm key
OG001
arm label
Arm B (Trametinib)
regimen
Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0005
arm key
OG000
arm label
Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
regimen
Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
analyzed count
98
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
outcome key
om-0005
arm key
OG001
arm label
Arm B (Trametinib)
regimen
Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02101788-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-micropapillary-serous-carcinoma
nct id
NCT02101788
harm key
EG000
source section id
NCT02101788-ae
event group key
EG000
event group label
Arm A - Control Arm
serious affected
43
serious at risk
127
other affected
124
other at risk
127
frequency threshold
0
collection period
Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
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-micropapillary-serous-carcinoma
nct id
NCT02101788
harm key
EG001
source section id
NCT02101788-ae
event group key
EG001
event group label
Arm B - Experimental Arm
serious affected
45
serious at risk
127
other affected
127
other at risk
127
frequency threshold
0
collection period
Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
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-micropapillary-serous-carcinoma
nct id
NCT02101788
harm key
EG002
source section id
NCT02101788-ae
event group key
EG002
event group label
Crossover From Control to Experimental Arm
serious affected
25
serious at risk
88
other affected
88
other at risk
88
frequency threshold
0
collection period
Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
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-micropapillary-serous-carcinoma
nct id
NCT02101788
qol key
qol-0004
source section id
NCT02101788-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-o' in the study's own wording
scale title
Patients Reported Acute Quality of Life
measure definition
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
time frame
1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patients who provided baseline and ≥ 1 follow-up assessment
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-micropapillary-serous-carcinoma
nct id
NCT02101788
qol key
qol-0005
source section id
NCT02101788-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Patient Reported Acute Peripheral Neuropathy Symptoms
measure definition
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
time frame
Up to 52 weeks
analysis role
secondary
reporting status
POSTED
higher is better
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direction quote
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population note
Patients that provided baseline and ≥ 1 follow-up assessment
curation status
draft
reviewed by
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reviewed at
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created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice