Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)NCT06984562
Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer
A study testing Adaptive Radiation Therapy in people with Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA), run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Adaptive Radiation Therapy (ART) is safe and effective in treating patients with locally advanced pancreatic cancer. The main questions the study aims to answer are: Can ART improve how well radiation therapy targets the most aggressive cancer cells, while protecting the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)
- What is being tested?
- Adaptive Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically-confirmed PDA.
- Patients must have locally advanced unresectable PDA.
- This includes the following- per NCCN criteria*: 2.1 Unreconstructible involvement with the superior mesenteric vein or portal vein due to tumor or bland thrombus OR 2.2 Solid tumor contact with greater than 180 degrees of the superior mesenteric artery or celiac artery OR 2.3. Solid tumor contact with the aorta OR 2.4. Patients with non-metastatic disease that is inoperable by virtue of the operation posing excessive risk to the patient
- All patients must have been reviewed in the multidisciplinary conference and determined to have unresectable disease by a pancreatic surgeon and to have received or be ineligible for induction chemotherapy based on medical oncology assessment. Documentation of this review in EPIC meeting minutes will satisfy this requirement.
- Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of chemotherapy must occur at least 2 weeks before start of ART.
- Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
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- Adequate bone marrow, hepatic, renal function:
- ANC ≥ 1,500/µl and PLT ≥ 100,000/µl
- Bilirubin less than 1.5 ULN
- AST and ALT < 3X ULN
- Serum Creatinine <1.5X ULN
- Women of childbearing potential must not be pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrheal and non-lactating for at least 12 months to be considered of non-childbearing potential. Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for at least 6 months after therapy is completed.
- 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, tissue sample collections, and follow-up.
Who cannot join
- Radiologically or cytologically confirmed metastatic disease.
- Patients who have had any prior radiation therapy for pancreatic cancer.
- Patients who have had prior chemoradiation to an overlapping volume.
- Patients with adenosquamous carcinoma of the pancreas.
- Subjects who have had chemotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier to < Grade 2. Patients who received previous immunotherapy or other antibody therapy, within 28 days (immune related toxicities must have resolved to <= Grade 2 prior to starting treatment). Study treatment may be started within these washout periods or with continuing toxicities if considered by the Sponsor-Investigator to be safe and within the best interest of the patient.
- Concurrent non-study chemotherapy or biologic therapy.
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- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
- Includes both bi- and mono-allelic likely pathogenic or pathogenic ATM mutations (VUS is acceptable).
- Serious, active infections requiring treatment with IV antibiotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Joshua Meyer, MD, 215-728-2667, Joshua.Meyer@fccc.edu
About this study
Official title: Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer: Phase I Dose Escalation Study
The goal of this clinical trial is to learn if Adaptive Radiation Therapy (ART) is safe and effective in treating patients with locally advanced pancreatic cancer.
The main questions the study aims to answer are:
Read more
- Can ART improve how well radiation therapy targets the most aggressive cancer cells, while protecting the healthy tissue around the tumor?
- Can ART help reduce the side effects that participants may experience during treatment?
Participants will:
- Undergo CT scans to plan the exact location of the radiation treatment. During this process, 1-3 small markers may be placed in or near the tumor to help with the planning.
- Have a tumor biopsy, which involves taking a small sample of tissue from the cancer.
- Receive 5 radiation treatments every other day over a 2-week period.
- Provide blood samples before, during, and after your radiation treatment.
- Being tested
- Adaptive Radiation Therapy
- Keywords
- Adaptive Radiation Therapy, Pancreatic Ductal Adenocarcinoma, Locally advanced unresectable PDA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Radiation TherapyRadiation
Adaptive Radiation Therapy (ART) creates a personalized radiation plan for each treatment session. This means the plan can change from day to day to more precisely target the tumor while protecting the surrounding healthy tissue.
By closely shaping the radiation to match the tumor's location, ART may reduce the amount of radiation reaching nearby normal tissues. This can allow for higher, more focused doses of radiation to the tumor itself, which may help improve treatment effectiveness while reducing side effects.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | Adaptive Radiation Therapy Receives: Radiation: Adaptive Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of acute and late grade ≥3 gastrointestinal toxicity occurring within 3 months of treatment possibly, probably or definitely related to radiation.
Measured: From start of radiation to 3 months after the end of radiation treatment
Secondary outcomes (3)
The proportion of patients experiencing local control defined as stable disease or any response at the radiation target site(s).
Measured: From the start of radiation to 5 years after end of radiation treatment
Overall Survival Rate - defined as the time from the start of radiation to death or last contact. Individuals who are alive at last follow-up will be considered censored at the time of last contact.
Measured: From the start of radiation to death or last contact (up to 5 years after end of treatment).
The rate of acute and late adverse events at time points prescribed in the study calendar using CTCAE version 5.0.
Measured: From start of radiation to end of long-term follow up (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start20 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)Studies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adaptive Radiation Therapy
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984562
- Sponsor's protocol ID
- RT-221
- Other IDs
- 25-1011
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer: Phase I Dose Escalation Study
- ClinicalTrials.gov ID
- NCT06984562
- Acronym / sponsor ID
- RT-221
- Keywords
- Adaptive Radiation Therapy, Pancreatic Ductal Adenocarcinoma, Locally advanced unresectable PDA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Adaptive Radiation Therapy (ART) is safe and effective in treating patients with locally advanced pancreatic cancer.
The main questions the study aims to answer are:
- Can ART improve how well radiation therapy targets the most aggressive cancer cells, while protecting the healthy tissue around the tumor?
- Can ART help reduce the side effects that participants may experience during treatment?
Participants will:
- Undergo CT scans to plan the exact location of the radiation treatment. During this process, 1-3 small markers may be placed in or near the tumor to help with the planning.
- Have a tumor biopsy, which involves taking a small sample of tissue from the cancer.
- Receive 5 radiation treatments every other day over a 2-week period.
- Provide blood samples before, during, and after your radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adaptive Radiation Therapy
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Radiation: Adaptive Radiation TherapyAdaptive Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histologically or cytologically-confirmed PDA.
- Patients must have locally advanced unresectable PDA.
- All patients must have been reviewed in the multidisciplinary conference and determined to have unresectable disease by a pancreatic surgeon and to have received or be ineligible for induction chemotherapy based on medical oncology assessment. Documentation of this review in EPIC meeting minutes will satisfy this requirement.
- Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of chemotherapy must occur at least 2 weeks before start of ART.
- Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
Key exclusion criteria (9 listed)
- Radiologically or cytologically confirmed metastatic disease.
- Patients who have had any prior radiation therapy for pancreatic cancer.
- Patients who have had prior chemoradiation to an overlapping volume.
- Patients with adenosquamous carcinoma of the pancreas.
- Subjects who have had chemotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier to < Grade 2. Patients who received previous immunotherapy or other antibody therapy, within 28 days (immune related toxicities must have resolved to <= Grade 2 prior to starting treatment). Study treatment may be started within these washout periods or with continuing toxicities if considered by the Sponsor-Investigator to be safe and within the best interest of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Radiation TherapyAdaptive Radiation Therapy (ART) creates a personalized radiation plan for each treatment session. This means the plan can change from day to day to more precisely target the tumor while protecting the surrounding healthy tissue. By closely shaping the radiation to match the tumor's location, ART may reduce the amount of radiation reaching nearby normal tissues. This can allow for higher, more focused doses of radiation to the tumor itself, which may help improve treatment effectiveness while reducing side effects. | Radiation | Single-Arm |
Primary outcome
The rate of acute and late grade ≥3 gastrointestinal toxicity occurring within 3 months of treatment possibly, probably or definitely related to radiation.
Time frame: From start of radiation to 3 months after the end of radiation treatment
3 secondary outcomes
The proportion of patients experiencing local control defined as stable disease or any response at the radiation target site(s).
Time frame: From the start of radiation to 5 years after end of radiation treatment
Overall Survival Rate - defined as the time from the start of radiation to death or last contact. Individuals who are alive at last follow-up will be considered censored at the time of last contact.
Time frame: From the start of radiation to death or last contact (up to 5 years after end of treatment).
The rate of acute and late adverse events at time points prescribed in the study calendar using CTCAE version 5.0.
Time frame: From start of radiation to end of long-term follow up (up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Meyer, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Radiation Therapy in people with Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA), run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Meyer, MD (215-728-2667, Joshua.Meyer@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of acute and late grade ≥3 gastrointestinal toxicity occurring within 3 months of treatment possibly, probably or definitely related to radiation. (time frame: From start of radiation to 3 months after the end of radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.