Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Tr

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 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

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

primary · POSTED

Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from step 1 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.

Eligible participants randomized at step 1.

→

primary · POSTED

Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.

Participants randomized at step 2.

→

secondary · POSTED

Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 1 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.

Eligible participants randomized at step 1.

→

secondary · POSTED

Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 2 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all participants have five years potential follow-up from second step randomization.

Participants randomized at step 2.

→

secondary · POSTED

Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Eligible participants randomized in Step 1 who started protocol treatment and were assessed for adverse events.

→

secondary · POSTED

Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death.

Participants randomized at step 2.

→

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 · Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group

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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id: NCT01013649
qol key: qol-0006
source section id: NCT01013649-om-0006
source outcome index: 6
instrument: FACT
instrument basis: matched 'fact-f' in the study's own wording
scale title: Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group
measure definition: Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from enrollment (step 1) to date of death from any cause or last known follow-up (censored). Baseline fatigue is measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-F) questionnaire which has a range of 0 to 52 with a higher score indicating less fatigue. Combining treatment arms, patients with low fatigue at baseline (FACIT-F score \> 30) will be compared to patients with high fatigue at baseline (FACIT-F scores ≤ 30).
time frame: From enrollment (step 1) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 13.2 years, measured from enrollment. Two- and five-year rates are reported here.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Eligible participants enrolled at step 1 who consented to the quality of life study component and have baseline FACT-F data.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

PROMIS · Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival

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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id: NCT01013649
qol key: qol-0007
source section id: NCT01013649-om-0007
source outcome index: 7
instrument: PROMIS
instrument basis: matched 'promis' in the study's own wording
scale title: Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival
measure definition: Baseline PROMIS Fatigue scores will be analyzed to determine if there is a cut point (adjusting for multiple comparisons) that correlates with overall survival using the log-rank statistic. The analysis population is all enrolled eligible participants who consented to the quality of life study component and who have baseline PROMIS data.
time frame: From enrollment to death or last follow-up.
analysis role: exploratory
reporting status: NOT_POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id: NCT01013649
trial label: Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Tr
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: 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: 6
harms Count: 4
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0000
source section id
NCT01013649-om-0000
source outcome index
0
endpoint
Overall Survival (Percentage of Participants Alive) [Phase II]
endpoint definition
Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from step 1 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.
time origin
From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants randomized at step 1.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0001
source section id
NCT01013649-om-0001
source outcome index
1
endpoint
Overall Survival (Percentage of Participants Alive) [Phase III]
endpoint definition
Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.
time origin
From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants randomized at step 2.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0002
source section id
NCT01013649-om-0002
source outcome index
2
endpoint
Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II]
endpoint definition
Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 1 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.
time origin
From step1 randomization (gemcitabine vs. gemcitabine/erlotinib) to disease event, death, or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Five-year rates are reported here.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants randomized at step 1.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0003
source section id
NCT01013649-om-0003
source outcome index
3
endpoint
Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]
endpoint definition
Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 2 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all participants have five years potential follow-up from second step randomization.
time origin
From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to disease event, death, or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants randomized at step 2.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0004
source section id
NCT01013649-om-0004
source outcome index
4
endpoint
Number of Participants by Highest Grade Adverse Event Reported (Phase II)
endpoint definition
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
time origin
From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants randomized in Step 1 who started protocol treatment and were assessed for adverse events.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0005
source section id
NCT01013649-om-0005
source outcome index
5
endpoint
Number of Participants by Highest Grade Adverse Event Reported (Phase III)
endpoint definition
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death.
time origin
From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants randomized at step 2.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0000
arm key
OG000
arm label
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
regimen
Patients receive either gemcitabine hydrochloride or \[starting 6-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
163
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0000
arm key
OG001
arm label
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
regimen
\[Closed to accrual 2-28-14.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
159
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0001
arm key
OG000
arm label
Arm III (Chemotherapy)
regimen
Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
174
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0001
arm key
OG001
arm label
Arm IV (Chemotherapy, Chemoradiotherapy)
regimen
Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (RT) (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
180
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0002
arm key
OG000
arm label
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
regimen
Patients receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
163
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0002
arm key
OG001
arm label
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
regimen
\[Closed to accrual 2-28-2014.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
159
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0003
arm key
OG000
arm label
Arm III (Chemotherapy)
regimen
Patients receive the same treatment as in arm I for 1 month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
174
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0003
arm key
OG001
arm label
Arm IV (Chemotherapy, Chemoradiotherapy)
regimen
Patients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
180
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0004
arm key
OG000
arm label
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
regimen
Patients receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
160
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0004
arm key
OG001
arm label
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
regimen
\[Closed to accrual 2-28-14.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
158
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0005
arm key
OG000
arm label
Arm III (Chemotherapy)
regimen
Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
174
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
outcome key
om-0005
arm key
OG001
arm label
Arm IV (Chemotherapy, Chemoradiotherapy)
regimen
Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
analyzed count
180
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01013649-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
harm key
EG000
source section id
NCT01013649-ae
event group key
EG000
event group label
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
serious affected
38
serious at risk
160
other affected
158
other at risk
160
frequency threshold
5
collection period
Arms I and II: From step 1 randomization (gemcitabine versus vs. gemcitabine/erlotinib) to the date of last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Arms III and IV: From the date of enrollment to the date of last follow-up. Maximum follow-up at time of phase III analysis was 13.2 years.
event definition
Note that adverse events from Arm I and II participants who continued to step 2 randomization will also appear in the adverse events for Arms III and IV.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
harm key
EG001
source section id
NCT01013649-ae
event group key
EG001
event group label
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
serious affected
45
serious at risk
158
other affected
157
other at risk
158
frequency threshold
5
collection period
Arms I and II: From step 1 randomization (gemcitabine versus vs. gemcitabine/erlotinib) to the date of last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Arms III and IV: From the date of enrollment to the date of last follow-up. Maximum follow-up at time of phase III analysis was 13.2 years.
event definition
Note that adverse events from Arm I and II participants who continued to step 2 randomization will also appear in the adverse events for Arms III and IV.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
harm key
EG002
source section id
NCT01013649-ae
event group key
EG002
event group label
Arm III (Chemotherapy)
serious affected
33
serious at risk
174
other affected
173
other at risk
174
frequency threshold
5
collection period
Arms I and II: From step 1 randomization (gemcitabine versus vs. gemcitabine/erlotinib) to the date of last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Arms III and IV: From the date of enrollment to the date of last follow-up. Maximum follow-up at time of phase III analysis was 13.2 years.
event definition
Note that adverse events from Arm I and II participants who continued to step 2 randomization will also appear in the adverse events for Arms III and IV.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
harm key
EG003
source section id
NCT01013649-ae
event group key
EG003
event group label
Arm IV (Chemotherapy, Chemoradiotherapy)
serious affected
31
serious at risk
180
other affected
179
other at risk
180
frequency threshold
5
collection period
Arms I and II: From step 1 randomization (gemcitabine versus vs. gemcitabine/erlotinib) to the date of last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Arms III and IV: From the date of enrollment to the date of last follow-up. Maximum follow-up at time of phase III analysis was 13.2 years.
event definition
Note that adverse events from Arm I and II participants who continued to step 2 randomization will also appear in the adverse events for Arms III and IV.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
qol key
qol-0006
source section id
NCT01013649-om-0006
source outcome index
6
instrument
FACT
instrument basis
matched 'fact-f' in the study's own wording
scale title
Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group
measure definition
Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from enrollment (step 1) to date of death from any cause or last known follow-up (censored). Baseline fatigue is measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-F) questionnaire which has a range of 0 to 52 with a higher score indicating less fatigue. Combining treatment arms, patients with low fatigue at baseline (FACIT-F score \> 30) will be compared to patients with high fatigue at baseline (FACIT-F scores ≤ 30).
time frame
From enrollment (step 1) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 13.2 years, measured from enrollment. Two- and five-year rates are reported here.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible participants enrolled at step 1 who consented to the quality of life study component and have baseline FACT-F data.
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-pancreatic-intraductal-papillary-mucinous-neoplasm
nct id
NCT01013649
qol key
qol-0007
source section id
NCT01013649-om-0007
source outcome index
7
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival
measure definition
Baseline PROMIS Fatigue scores will be analyzed to determine if there is a cut point (adjusting for multiple comparisons) that correlates with overall survival using the log-rank statistic. The analysis population is all enrolled eligible participants who consented to the quality of life study component and who have baseline PROMIS data.
time frame
From enrollment to death or last follow-up.
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
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