Clinical trial · Interventional
Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer
RT-155: Utilizing Pulsed Low-dose-rate (PLDR) Radiation to Prevent de Novo Stromal Activation; a Neoadjuvant Pancreatic Adenocarcinoma Phase I Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Standard chemoradiation, followed by surgery are standard treatment plan for patients suffering from pancreatic adenocarcinoma. Due to damage to the surrounding healthy tissue caused by standard radiation, this study uses a new type of radiation plan- pulsed low-dose rate (PLDR) radiation , in combination with chemotherapeutic drug, gemcitabine, given weekly along with the radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PLDR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PLDR Chemoradiation
- description
- Patients will receive pulse-low-dose rate radiation, along with gemcitabine chemotherapy. 6 patients each will be accrued at two dose levels. PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows: Dose level 1: 56 Gy; Dose level 2: 66 Gy
- interventionNames
- Radiation: PLDR
Primary outcomes (1)
- measure
- Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation.
- timeFrame
- 11 weeks
- description
- Number of participants with Grade 3 toxicity related to the treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma.
* Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection. This includes the following:
* Any involvement (defined as loss of fat plane on contrast CT) of any of the following vessels\*:
* Common hepatic artery
* Superior mesenteric artery
* Celiac axis
* Superior mesenteric vein
* Portal vein
* Aorta
* These criteria will be judged by the operating surgeon in conjunction with a radiologist prior to enrollment.
* Poor performance status not immediately conducive to radical surgery
* Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation
* Patients must have evaluable disease as measured by RECIST 1.1 criteria.
* Planned surgical resection at the time of enrollment (may be initially staged as resectable, borderline resectable, or locally-advanced/unresectable).
* Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
* Adequate bone marrow, hepatic, renal function.
* ANC ³ 1,500/ml and PLT ³ 100,000/ml
* Bilirubin less than 1.5 ULN
* AST and ALT \< 3X ULN
* Serum Creatinine \<1.5X ULN
* Prior chemotherapy allowed, but not mandatory. Patients who have undergone chemotherapy prior to participating in this study must have had a 2 week washout period at the time of signing the consent form.
* Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration. Postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed. Please refer to section 6.4 for additional detail.
* Age \> 18 years
* Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
Exclusion Criteria:
* Radiological or cytologically confirmed metastatic disease
* Patients who have had any prior therapy for pancreatic cancer, except chemotherapy (see 6.1.7)
* Concurrent non-study chemotherapy or biologic therapy
* A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
* Scleroderma or active connective tissue disease
* Active inflammatory bowel disease
* Serious, active infections requiring treatment with IV antibiotics
* Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.References
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