Trial · NCT01013649
Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
NCT01013649, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2024-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery. Trials, record NCT01013649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01013649
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
- NCT number
- NCT01013649
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 546 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Stage I Pancreatic Cancer AJCC v6 and v7, Stage II Pancreatic Cancer AJCC v6 and v7
- Interventions
3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, Capecitabine, Chemotherapy, Computed Tomography, Erlotinib Hydrochloride, Fluorouracil, Gemcitabine Hydrochloride, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Quality-of-Life Assessment, X-Ray Imaging
- First posted
- 2009-11-16
- Last updated
- 2026-02-23
- Results first posted
- 2024-10-24
- Limitations and caveats
Based on negative results from trial NCT00634725 regarding the question of gemcitabine versus gemcitabine plus erlotinib in locally unresectable pancreatic cancer patients, this study was amended to stop the erlotinib randomization and to change the erlotinib question to a randomized phase II design using the patients already randomized.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (Percentage of Participants Alive) [Phase II] | 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. | 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. |
| Primary | Overall Survival (Percentage of Participants Alive) [Phase III] | 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. | 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. |
| Secondary | Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II] | 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. | 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. |
| Secondary | Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III] | 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. | 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. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported (Phase II) | 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. | 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. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported (Phase III) | 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. | 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. |
| Secondary | Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group | 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. | 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). |
| Other | Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival | From enrollment to death or last follow-up. | 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. |
| Other | Frequency of Objective Criteria of Resectability as Measured by Preoperative Imaging | Baseline | |
| Other | Overall Survival (Percentage of Participants Alive) [Phase III] by Sex | 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. | NIH-required analysis. 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (Percentage of Participants Alive) [Phase II] | 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. | Eligible participants randomized at step 1. | months | MEDIAN |
| PRIMARY | Overall Survival (Percentage of Participants Alive) [Phase III] | 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. | Participants randomized at step 2. | months | MEDIAN |
| SECONDARY | Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II] | 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. | Eligible participants randomized at step 1. | months | MEDIAN |
| SECONDARY | Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III] | 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. | Participants randomized at step 2. | months | MEDIAN |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported (Phase II) | 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. | Eligible participants randomized in Step 1 who started protocol treatment and were assessed for adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported (Phase III) | 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. | Participants randomized at step 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group | 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. | Eligible participants enrolled at step 1 who consented to the quality of life study component and have baseline FACT-F data. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival | From enrollment to death or last follow-up. | |||
| OTHER_PRE_SPECIFIED | Frequency of Objective Criteria of Resectability as Measured by Preoperative Imaging | Baseline | |||
| OTHER_PRE_SPECIFIED | Overall Survival (Percentage of Participants Alive) [Phase III] by Sex | 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. | Participants randomized at step 2. Data were stratified by sex. | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (Percentage of Participants Alive) [Phase II] | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 29.9 | 95% Confidence Interval 21.7 to 33.4 | months | |
| Overall Survival (Percentage of Participants Alive) [Phase II] | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 28.1 | 95% Confidence Interval 20.7 to 30.9 | months | |
| Overall Survival (Percentage of Participants Alive) [Phase III] | Arm III (Chemotherapy) | 31.1 | 90% Confidence Interval 25.3 to 37.6 | months | |
| Overall Survival (Percentage of Participants Alive) [Phase III] | Arm IV (Chemotherapy, Chemoradiotherapy) | 27.3 | 90% Confidence Interval 24.5 to 31.7 | months | |
| Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II] | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 12.7 | 95% Confidence Interval 10.8 to 15.7 | months | |
| Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II] | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 12.4 | 95% Confidence Interval 9.7 to 16.5 | months | |
| Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III] | Arm III (Chemotherapy) | 12.4 | 90% Confidence Interval 9.6 to 15.2 | months | |
| Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III] | Arm IV (Chemotherapy, Chemoradiotherapy) | 15.6 | 90% Confidence Interval 13.2 to 18.8 | months | |
| Number of Participants by Highest Grade Adverse Event Reported (Phase II) | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | Grade 1 | 6 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported (Phase II) | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | Grade 1 | 3 | Participants |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Step | STARTED | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 379 | |
| First Step | STARTED | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 167 | |
| First Step | STARTED | Arm III (Chemotherapy) | 0 | |
| First Step | STARTED | Arm IV (Chemotherapy, Chemoradiotherapy) | 0 | |
| First Step | Randomized to Arm I or Arm II | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 169 | |
| First Step | Randomized to Arm I or Arm II | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 167 | |
| First Step | Randomized to Arm I or Arm II | Arm III (Chemotherapy) | 0 | |
| First Step | Randomized to Arm I or Arm II | Arm IV (Chemotherapy, Chemoradiotherapy) | 0 | |
| First Step | Registered to Arm 1 Only | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 210 | |
| First Step | Registered to Arm 1 Only | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events800
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 122 | 160 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 119 | 158 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III (Chemotherapy) | 139 | 174 | |
| other | Anemia | Blood and lymphatic system disorders | Arm IV (Chemotherapy, Chemoradiotherapy) | 142 | 180 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 10 | 160 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 11 | 158 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm III (Chemotherapy) | 11 | 174 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm IV (Chemotherapy, Chemoradiotherapy) | 11 | 180 | |
| other | Blurred vision | Eye disorders | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 6 | 160 | |
| other | Blurred vision | Eye disorders | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 5 | 158 |
1 to 10 of 800Source ClinicalTrials.gov
See all 800 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 103 | 160 |
| Total, all-cause mortality | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 100 | 158 |
| Total, all-cause mortality | Arm III (Chemotherapy) | 136 | 174 |
| Total, all-cause mortality | Arm IV (Chemotherapy, Chemoradiotherapy) | 134 | 180 |
| Total, other adverse events | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 158 | 160 |
| Total, other adverse events | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 157 | 158 |
| Total, other adverse events | Arm III (Chemotherapy) | 173 | 174 |
| Total, other adverse events | Arm IV (Chemotherapy, Chemoradiotherapy) | 179 | 180 |
| Total, serious adverse events | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 38 | 160 |
| Total, serious adverse events | Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 45 | 158 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants3
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA180830 | NCI NCTN- Network Lead Academic Participating Site: USC | LENZ, HEINZ JOSEF; EL-KHOUEIRY, ANTHONY BOUTROS; QUINN, DAVID IAN | UNIVERSITY OF SOUTHERN CALIFORNIA | NATIONAL CANCER INSTITUTE | 2014 to 2018 | NIH RePORTER |
| U10CA021661 | Radiation Therapy Oncology Group | CURRAN, WALTER J. | AMERICAN COLLEGE OF RADIOLOGY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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