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2025-10-08
2030-10-21
2030-10-21
356
NCT06958328
NRG Oncology
NRG Oncology
INTERVENTIONAL
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 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 OBJECTIVE: I. To evaluate whether dose-escalated radiation therapy (RT) improves 3-year overall survival (OS) compared to standard treatments without dose-escalated RT, in locally advanced pancreatic cancer patients without radiographic progression and with biochemical response after an initial interval of chemotherapy. SECONDARY OBJECTIVES: I. To evaluate and compare local progression between the two treatment arms. II. To evaluate and compare progression-free survival (PFS) between the two treatment arms. III. To evaluate and compare chemotherapy-free interval between the two treatment arms. IV. To evaluate and compare toxicity within and between the two treatment arms. HEALTH-RELATED QUALITY-OF-LIFE (HRQOL) OBJECTIVES: I. Primary: To compare Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Total Score at 6 months between the two treatment arms. II. Secondary: To compare nadir of HRQoL scores over course of study participation between the two treatment arms. III. Secondary: To evaluate HRQoL scores over time between the two treatment arms. EXPLORATORY OBJECTIVE: I. Biospecimen collection for future correlative analyses. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (STANDARD OF CARE): Patients are assigned to 1 of 3 treatment options per physician's decision. OPTION 1: Patients continue to receive fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX or modified FOLFIRINOX [mFOLFIRINOX]) or fluorouracil, liposomal irinotecan, leucovorin calcium, and oxaliplatin (NALIRIFOX) or gemcitabine/nab-paclitaxel per standard of care for a total of 6 months of treatment. Patients may continue treatment beyond 6 months at physician's discretion. OPTION 2: Patients undergo standard dose radiation therapy once daily for 28 fractions and receive fluorouracil or capecitabine per standard of care during radiation therapy. After completing concurrent chemoradiation, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. OPTION 3: Patients undergo observation per standard of care. (It is recommended [but not required] that this option only be for patients that have already completed total 6 months chemotherapy pre-randomization.) Additionally, patients undergo blood sample collection, computed tomography (CT), magnetic resonance imaging (MRI) and tumor tissue biopsy throughout the study. ARM II (DOSE-ESCALATED RADIATION THERAPY): Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluoropyrimidine). After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years then annually for 3 years.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-04-25 | N/A | 2025-07-22 |
2025-04-25 | N/A | 2025-07-23 |
2025-05-06 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Arm I (standard of care) 1: Patients continue to receive fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin or fluorouracil, liposomal irinotecan, leucovorin calcium, and oxaliplatin or gemcitabine/nab-paclitaxel per standard of care for a total of 6 mont | DRUG: Fluorouracil
DRUG: Irinotecan Hydrochloride
DRUG: leucovorin calcium
DRUG: Oxaliplatin
DRUG: Irinotecan Sucrosofate
DRUG: Gemcitabine
DRUG: Nab paclitaxel
RADIATION: Radiation Therapy
DRUG: Capecitabine
OTHER: Observation Activity
PROCEDURE: Biospecimen Collection
PROCEDURE: Biopsy Procedure
PROCEDURE: Computed Tomography
PROCEDURE: Magnetic Resonance Imaging
OTHER: Questionnaire Administration
|
| EXPERIMENTAL: ARM II (DOSE-ESCALATED RADIATION THERAPY): ): Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluoropyrimidine). After completing dose-escalated RT, patients who received less than 6 months of chemothe | RADIATION: Dose-escalated Radiation Therapy
PROCEDURE: Biospecimen Collection
PROCEDURE: Biopsy Procedure
PROCEDURE: Computed Tomography
PROCEDURE: Magnetic Resonance Imaging
OTHER: Questionnaire Administration
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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. | assessed up to 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Local progression (LP) | 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). | From randomization to date of failure, date of death (competing event), or last known follow-up date, assessed up to 5 years |
| Progression-free survival (PFS) | 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). | 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 |
| Chemotherapy-free interval (CFI) | 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. | 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 |
| Long-term radiation-related ≥ grade 3 adverse events | The percentage of patients on the dose-escalated radiation therapy arm will be reported | Up to 1 year |
| Incidence of ≥ grade 3 adverse events | The percentage of patients will be compared between the treatment arms using a Z-test. | Up to 90 days after randomization |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Nina Sanford Phone Number: Email: Nina.Sanford@UTSouthwestern.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
