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NCT06958328 · ClinicalTrials.gov registry record · Phase 3
Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
A Phase 3 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
- 20
- Study locations
NCT06958328: Recruiting Phase 3 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, sponsored by NRG Oncology.
NCT06958328 is a Phase 3 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 356 participants, above the 77-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (362% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06958328, a Phase 3 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.
Primary Outcome
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 pla
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- PROCEDURE Biopsy Procedure
- RADIATION Dose-escalated Radiation Therapy
Study Locations (20)
California
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills-Peninsula Medical Center - Burlingame
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Palo Alto Medical Foundation-Fremont - Fremont
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- Memorial Medical Center - Modesto
- Palo Alto Medical Foundation-Camino Division - Mountain View
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Palo Alto Medical Foundation Health Care - Palo Alto
- Stanford Cancer Institute Palo Alto - Palo Alto
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Arizona Center for Cancer Care - Gilbert - Gilbert
- Arizona Center for Cancer Care-Peoria - Peoria
- Arizona Center for Cancer Care - Phoenix - Phoenix
- Arizona Center for Cancer Care - Scottsdale - Scottsdale
- Arizona Center for Cancer Care-Surprise - Surprise
- Arizona Center for Cancer Care - Tempe
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2025-08-21 |
| Est. Completion | 2030-10-21 |
| Phase | Phase 3 |
What NCT06958328 shows while recruiting
NCT06958328 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (362% higher).
The record links to 4 conditions, with Stage IV Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06958328 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06958328 about?
NCT06958328 is a clinical study titled "Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer". This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or stan...
What is the current status of trial NCT06958328?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2025-08-21. Estimated completion is 2030-10-21.
What conditions does trial NCT06958328 study?
This clinical trial studies the following conditions: Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT06958328?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Biopsy Procedure (PROCEDURE), Dose-escalated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06958328?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06958328 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Pancreatic Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06958328's enrollment target sits among peer trials
356 2nd of 31 the highest of 31 other Stage IV Pancreatic Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Pancreatic Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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