Trial · NCT06958328
Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
NCT06958328, Phase 3, Recruiting, NRG Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer. Trials, record NCT06958328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06958328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
- NCT number
- NCT06958328
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 356 participants, estimated
- Lead sponsor
- NRG Oncology
- Conditions
- Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Interventions
Biopsy Procedure, Biospecimen Collection, Capecitabine, Computed Tomography, Dose-escalated Radiation Therapy, Fluorouracil, Gemcitabine, Irinotecan Hydrochloride, Irinotecan Sucrosofate, Leucovorin Calcium, Magnetic Resonance Imaging, Nab-paclitaxel, Observation Activity, Oxaliplatin, Positron Emission Tomography, Questionnaire Administration, Radiation Therapy, Tumor Treating Fields Therapy
- First posted
- 2025-05-06
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | From randomization to the date of death or last follow-up, assessed up to 3 years | OS will be estimated by the Kaplan-Meier method (Kaplan 1958). The 3-year OS estimates between the two arms will be compared using a Z-test. A logistic regression model will be used to analyze the effects of factors, in addition to treatment, including, but not limited to the stratification factor, which may be associated with 3-year OS. The primary hypothesis of improved 3-year OS will be tested with a 1-sided significance level of 0.023 (level based on not having stopped at either of the 2 planned interim analyses). |
| Secondary | Local progression (LP) | From randomization to date of failure, date of death (competing event), or last known follow-up date, assessed up to 5 years | Defined as progression of the primary tumor/nodes as determined by Response Evaluation Criteria in Solid Tumors criteria. LP will be estimated by the cumulative incidence method (Kalbfleish 1980), with death as a competing risk, and compared between treatment arms using Gray's test (Gray 1988). The Fine-Gray regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with LP (Fine 1999). |
| Secondary | Progression-free survival (PFS) | From the date of randomization to the date of first PFS failure or last follow-up for patients without a reported PFS event, assessed up to 5 years | Defined as local progression, distant failure, or death due to any cause. PFS will be estimated by the Kaplan-Meier method (Kaplan 1958) and estimates between treatment arms will be compared using the log-rank test (Mantel 1966). The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with PFS (Cox 1972). |
| Secondary | Chemotherapy-free interval (CFI) | From the date of last dose of initial chemotherapy to the date of first dose of second line chemotherapy for progression, assessed up to 5 years | Defined as the time in months without chemotherapy for locally advanced pancreatic cancer post the initial chemotherapy treatment. Mean CFI will be compared between treatment arms using a Z-test. Regression modeling will be used to analyze the effects of factors, in addition to treatment, which may be associated with CFI. |
| Secondary | Long-term radiation-related ≥ grade 3 adverse events | Up to 1 year after randomization | The percentage of patients on the dose-escalated radiation therapy arm will be reported. |
| Secondary | Incidence of ≥ grade 3 adverse events | Up to 90 days after randomization | The percentage of patients will be compared between the treatment arms using a Z-test. |
| Other | Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score at 6 months | At 6 months | Mean FACT-Hep total score at 6 months will be compared between treatment arms using a t-test, if normality is met, or Wilcoxon test if not. Regression modeling will be used to analyze the effects of factors (e.g. stratification factor and other relevant baseline factors), in addition to treatment, that may be associated with 6-month mean FACT-Hep Total Score. |
| Other | FACT-Hep score nadir | From baseline to 24 months from randomization | The nadir is defined as the lowest score after baseline assessment. Mean nadir (for each of total score and Hep subscale) will be compared between treatment arms using a t-test, if normality is met, or Wilcoxon test if not, using 2-sided alpha=0.01 to account for multiple comparisons. |
| Other | FACT-Hep total score over time | From baseline to 24 months from randomization | Longitudinal analyses incorporating all follow-up time points will be done using longitudinal linear modeling methods to assess FACT-Hep Total Score trends across time. Baseline scores, treatment arm, time, treatment by time interaction (if significant), the stratification factor, and relevant covariates will be included in the model analyses. Other than baseline score, treatment arm, and time, only covariates with a 2-sided p-value \< 0.01, to account for multiple comparisons, will be retained in the model. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| 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 |
Source 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.
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/NCT06958328
GET https://conductscience.org/api/trials/v1/NCT06958328/registered