TriangleNCT01535053 · STUDY IN CONTEXT
Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
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
Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
Maximum grade of physician assessed adverse events reported during treatment
The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
Reported safety
Quality of life and patient-reported measures
FACT · Patient-reported Quality of Life (QOL) at Baseline
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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- qol key
- qol-0004
- source section id
- NCT01535053-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact-g' in the study's own wording
- scale title
- Patient-reported Quality of Life (QOL) at Baseline
- measure definition
- Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
- time frame
- Prior to cycle 1
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Provided baseline QOL questionnaire
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Patient-reported Quality of Life (QOL) After Baseline Visit.
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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- qol key
- qol-0005
- source section id
- NCT01535053-om-0005
- source outcome index
- 5
- instrument
- FACT
- instrument basis
- matched 'fact-g' in the study's own wording
- scale title
- Patient-reported Quality of Life (QOL) After Baseline Visit.
- measure definition
- Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
- time frame
- Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Provided baseline and ≥1 follow-up assessments
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- trial label
- Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
- 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
- 2
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0000
- source section id
- NCT01535053-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Complete Response
- endpoint definition
- Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
- time origin
- hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0001
- source section id
- NCT01535053-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
- endpoint definition
- Maximum grade of physician assessed adverse events reported during treatment
- time origin
- Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0002
- source section id
- NCT01535053-om-0002
- source outcome index
- 2
- endpoint
- The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
- endpoint definition
- The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
- time origin
- Anytime during post treatment follow-up for up to 2 years from study entry.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Non-responding eligible patients in follow-up
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0003
- source section id
- NCT01535053-om-0003
- source outcome index
- 3
- endpoint
- The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
- endpoint definition
- The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
- time origin
- Anytime during post treatment follow-up for up to 2 years from study entry.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Non-responding eligible patients in follow-up
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0004
- source section id
- NCT01535053-om-0004
- source outcome index
- 4
- endpoint
- Patient-reported Quality of Life (QOL) at Baseline
- endpoint definition
- Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
- time origin
- Prior to cycle 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Provided baseline QOL questionnaire
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0005
- source section id
- NCT01535053-om-0005
- source outcome index
- 5
- endpoint
- Patient-reported Quality of Life (QOL) After Baseline Visit.
- endpoint definition
- Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
- time origin
- Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Provided baseline and ≥1 follow-up assessments
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Regimen I (Dactinomycin)
- regimen
- IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Regimen II (Methotrexate)
- regimen
- institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Regimen I (Dactinomycin)
- regimen
- IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Regimen II (Methotrexate)
- regimen
- institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Regimen I (Dactinomycin)
- regimen
- IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Regimen II (Methotrexate)
- regimen
- institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Regimen I (Dactinomycin)
- regimen
- IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Regimen II (Methotrexate)
- regimen
- institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Regimen I (Dactinomycin)
- regimen
- IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Regimen II (Methotrexate)
- regimen
- institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Regimen I (Dactinomycin)
- regimen
- IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Regimen II (Methotrexate)
- regimen
- institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535053-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- harm key
- EG000
- source section id
- NCT01535053-ae
- event group key
- EG000
- event group label
- Regimen I (Dactinomycin)
- serious affected
- 1
- serious at risk
- 28
- other affected
- 27
- other at risk
- 28
- frequency threshold
- 0
- collection period
- Through Study Treatment and up to 30 days after discontinuing treatment.
- event definition
- Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- harm key
- EG001
- source section id
- NCT01535053-ae
- event group key
- EG001
- event group label
- Regimen II (Methotrexate)
- serious affected
- 1
- serious at risk
- 26
- other affected
- 24
- other at risk
- 26
- frequency threshold
- 0
- collection period
- Through Study Treatment and up to 30 days after discontinuing treatment.
- event definition
- Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- qol key
- qol-0004
- source section id
- NCT01535053-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact-g' in the study's own wording
- scale title
- Patient-reported Quality of Life (QOL) at Baseline
- measure definition
- Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
- time frame
- Prior to cycle 1
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Provided baseline QOL questionnaire
- 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-gestational-trophoblastic-tumor
- nct id
- NCT01535053
- qol key
- qol-0005
- source section id
- NCT01535053-om-0005
- source outcome index
- 5
- instrument
- FACT
- instrument basis
- matched 'fact-g' in the study's own wording
- scale title
- Patient-reported Quality of Life (QOL) After Baseline Visit.
- measure definition
- Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale 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 subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
- time frame
- Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Provided baseline and ≥1 follow-up assessments
- 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