Trial · NCT02839343
Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer
NCT02839343, Phase 2, Unknown, Alliance for Clinical Trials in Oncology; results first posted 2022-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer. Trials, record NCT02839343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02839343
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer
- NCT number
- NCT02839343
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Pancreatic Adenocarcinoma, Borderline Resectable Adenocarcinoma of the Head of the Pancrease
- Interventions
- radiation therapy, surgery, mFOLFIRINOX, FOLFOX
- First posted
- 2016-07-20
- Last updated
- 2022-05-24
- Results first posted
- 2022-05-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Rate | 18 months | Defined as the percentage of patients who are alive at 18 months after randomization divided by the total number of evaluable patients in each arm. An evaluable patient is defined as any patient who signed informed consent, deemed eligible by central review and received any protocol-defined treatment. 95% confidence interval will be estimated based on standard method. Chi-squared test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare 18 month OS rates among treatment arms. OS within each arm will be summarized by Kaplan-Meier method. Median, 1-year and 2-year rates will be estimated based on Kaplan-Meier curves. |
| Secondary | Residual Tumor (R)0 Resection Rate | 24 months | Defined as the percentage of patients in whom an achieved R0 resection was achieved during surgery. |
| Secondary | Event-free Survival | 4 years and 7 months | Defined as time from randomization to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death due to any cause. Will be estimated using the method of Kaplan-Meier in each arm and compared between treatment groups using the log-rank test. The correlation between pathologic complete response (pCR) status and event-free survival time will be assessed by Cox model with landmark approach. |
| Secondary | Pathologic Complete Rate (pCR) Rate | 24 months | Defined as the percentage of patients in whom a pCR was confirmed by histopathologic review of the surgical specimen. Chi-square test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare pCR resection rate between two treatment arms. Sensitivity analysis will be conducted among patients in cohort 1) and cohort 2). The association between pCR rate and OS/progression free survival (PFS) will be assessed by log-rank test and Cox model. |
| Secondary | Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE | 1 year | Overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) Rate | 18 months | Excluded from analysis were 6 patients that withdrew or progressed prior to treatment. | percentage of patients | NUMBER |
| SECONDARY | Residual Tumor (R)0 Resection Rate | 24 months | Excluded from analysis were 6 patients that withdrew or progressed prior to treatment. | percentage of patients | NUMBER |
| SECONDARY | Event-free Survival | 4 years and 7 months | Excluded from analysis were 6 patients that withdrew or progressed prior to treatment. | Months | MEDIAN |
| SECONDARY | Pathologic Complete Rate (pCR) Rate | 24 months | Excluded from analysis were 6 patients that withdrew or progressed prior to treatment. | percentage of patients | NUMBER |
| SECONDARY | Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE | 1 year | All patients that were treated and assessed for adverse events | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) Rate | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 64.6 | percentage of patients | ||
| Overall Survival (OS) Rate | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 47.3 | percentage of patients | ||
| Residual Tumor (R)0 Resection Rate | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 49 | percentage of patients | ||
| Residual Tumor (R)0 Resection Rate | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 35 | percentage of patients | ||
| Event-free Survival | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 15.0 | 95% Confidence Interval 11.2 to 21.9 | Months | |
| Event-free Survival | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 10.2 | 95% Confidence Interval 6.7 to 17.3 | Months | |
| Pathologic Complete Rate (pCR) Rate | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 0 | percentage of patients | ||
| Pathologic Complete Rate (pCR) Rate | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 11 | percentage of patients | ||
| Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 66 | Participants | ||
| Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 55 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 70 | |
| Overall Study | STARTED | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 56 | |
| Overall Study | COMPLETED | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 65 | |
| Overall Study | COMPLETED | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 55 | |
| Overall Study | NOT COMPLETED | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 5 | |
| Overall Study | NOT COMPLETED | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 1 |
Source ClinicalTrials.gov
Adverse events496
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 1 (mFOLFIRINOX + Surgery + FOLFOX) | 35 | 66 | 118 |
| other | Anemia | Blood and lymphatic system disorders | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 24 | 55 | 112 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 2 | 66 | 2 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 1 | 55 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 1 | 66 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 0 | 55 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 1 | 66 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 2 | 55 | 2 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 0 | 66 | 0 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 1 | 55 | 1 |
1 to 10 of 496Source ClinicalTrials.gov
See all 496 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 42 | 66 |
| Total, all-cause mortality | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 26 | 55 |
| Total, other adverse events | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 64 | 66 |
| Total, other adverse events | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 55 | 55 |
| Total, serious adverse events | Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 33 | 66 |
| Total, serious adverse events | Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 28 | 55 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) vs Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx): Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE | Trial comparisons |
| Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) vs Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx): deaths from any cause | Trial comparisons |
| Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) vs Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx): serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02839343
GET https://conductscience.org/api/trials/v1/NCT02839343/events?page=2