Pancreatic AdenocarcinomaPhase 1/2NCT06024824
Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)
A Phase 1/2 study testing Dose-Painted Intensity Modulated Radiotherapy in people with Pancreatic Adenocarcinoma, run by Cancer Trials Ireland at 2 sites in Ireland.
Trial summary
This is a prospective non-randomised Phase I/II Radiotherapy (RT) study with patients recruited to escalated dose cohorts. Patients with resectable or borderline resectable (per the National Comprehensive Cancer Network (NCCN) criteria) pancreatic adenocarcinoma will receive dose-escalated hypofractionated DP-IMRT via… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Dose-Painted Intensity Modulated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesIreland
- Study dates
- 30 Jan 2024to Jul 2031
- Phase
- Phase 1/2
- 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
- Written informed consent obtained prior to any study-related procedures
- Age ≥18 years
- ECOG (European Cooperative Oncology Group) performance status (PS) 0-2
- Resectable or borderline resectable per National Comprehensive Cancer Network (NCCN) criteria (see Appendix H)
- Patients with histologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC), with the following staging: cT1N0-2, cT2N0-2, cT3N0-2 [American Joint Committee on Cancer (AJCC) 8th edition] (see Appendix C) who are planned for pre-operative systemic chemo-radiotherapy
- Imaging with Computed Tomography Thorax Abdomen and Pelvis (CT TAP) and Magnetic resonance imaging (MRI) Abdomen confirms no evidence of metastatic disease
- Females of child-bearing potential (see Appendix G) must not be pregnant (or lactating) and must be prepared to use adequate contraception methods during treatment. Males whose female partners are of child-bearing potential must be prepared to use adequate contraception methods during treatment.
Who cannot join
- Previous thoracic or abdominal or pelvic radiation therapy (RT)
- Previous treatment for bilirubin regression, other than stenting
- Known co-existing or prior malignancy within the last 5 years (except for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin) which is likely to interfere with treatment or assessment of outcomes
- Syndromes or conditions associated with increased radiosensitivity
- Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes, or psychiatric illness/ social situations that would limit compliance with study requirements
- Evidence of any other significant clinical disorder or laboratory findings that makes it undesirable for the patient to participate in the study, or if it is felt by the research/ Medical team that the patient may not be able to comply with the protocol and follow up schedule due to psychological, familial, sociological or geographical conditions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland2 sites, 2 recruiting
- Recruiting
St Luke's Radiation Oncology Network (SLRON)
Dublin
Dr Gerard McVey
- Recruiting
St Vincent's University Hospital
Dublin
Dr Gerard McVey
About this study
Official title: DP-IMRT Pancreas: A Non-randomised Phase I/II Study of Dose-escalated Hypofractionated Dose-Painted Intensity Modulated Radiotherapy (DPIMRT) in Resectable/Borderline Resectable Pancreatic Adenocarcinoma
This is a prospective non-randomised Phase I/II Radiotherapy (RT) study with patients recruited to escalated dose cohorts. Patients with resectable or borderline resectable (per the National Comprehensive Cancer Network (NCCN) criteria) pancreatic adenocarcinoma will receive dose-escalated hypofractionated DP-IMRT via Intensity Modulated Radiotherapy (IMRT) / Volume Modulated Arc Therapy (VMAT).
Read the detailed description
The study treatment is radiotherapy. Different doses of radiotherapy will be given to patients. The first group of patients will receive the lowest dose (dose level 1) (this is the dose delivered to patients as standard of care). If the treatment does not cause serious side effects, it will be given to the next group of patients enrolled at a higher dose (dose level 2) (this is called 'dose escalation'). If this higher dose of treatment does not cause serious side effects, the next group of patients will receive a higher dose (dose level 3). The doses will continue to increase for every group of patients, as long as no serious side effects occur. If this happens, the study is halted. Once the optimum dose level has been reached, a larger cohort of patients will all receive this dose.
Phase I: A 3+3 dose escalation design is proposed to determine the maximum tolerated dose (MTD) defined by the number of radiotherapy-related ≥ Grade 3 acute toxicities assessed up to 4 weeks post RT. Three cohorts of between 3 and 6 patients at each dose level will be accrued in order to establish the MTD (minimum of 6, maximum of 18 patients). The MTD defined in Phase I will be the dose which will be used in Phase II of the trial. Phase II: 49 patients: Once the MTD is established, patients will continue to be recruited at that dose level up to a total of 49 patients.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Dose-Painted Intensity Modulated Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-Painted Intensity Modulated RadiotherapyRadiation
Fifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT/ VMAT.
Cohort 1 (n = 3-6) Single PTV 40.05 Gy/15#, homogenous dose. Cohort 2 (n = 3-6) High Risk PTV 45 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions.
Cohort 3 (n = 3-6) High risk PTV 48 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions.
| Study group | Role | What they receive |
|---|---|---|
| Radiation; IMRT | Experimental | Fifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT/ VMAT. Cohort 1 (n = 3-6) Single PTV 40.05 Gy/15#, homogenous dose* Cohort 2 (n = 3-6) High Risk PTV 45 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions* Cohort 3 (n = 3-6) High risk PTV 48 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions
* Progression to the next dose in successive cohorts depends on the number of patients experiencing DLTs within 4 weeks post-RT treatment in each patient cohort. Receives: Radiation: Dose-Painted Intensity Modulated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - to establish the MTD in a dose-escalated and hypofractionated RT regime delivered via IMRT/VMAT by the number of DLTs
To establish the MTD in a dose-escalated and hypofractionated RT regime delivered via IMRT/VMAT by the number of DLTs, and the rate of patient withdrawal from trial treatment due to DLTs. Analysis will be performed for each cohort after all patients have been assessed for their 4-week post RT assessment.
Measured: 4 weeks
Phase 2 - to determine the frequency and severity of DLTs due to AE/Toxicity meeting definition of DLT at 4 weeks post RT
The rate of DLTs up to 4 weeks post RT will be calculated. This proportion along with the 90% confidence intervals will be reported.
Measured: 4 weeks
Phase 2 - to determine the rate of patient withdrawal from trial treatment due to AE/Toxicity meeting definition of DLT at 4 weeks post RT
The rate of withdrawal from trial treatment of patients due to DLTs will be calculated. This proportion along with the 90% Confidence Interval will be reported. Other toxicity data including SAEs will be summarised and presented in tabular format with proportions plus 95% Confidence Interval where appropriate.
Measured: 4 weeks
Secondary outcomes (9)
To quantify the percentage of histologically proven R0 resections in the trial patient group (R0 to be defined as a minimal clearance of at least1 mm).
The percentage of histologically proven R0 resections in this patient group (R0 to be defined as a minimal clearance of at least 1 mm) will be presented with 95% Confidence Interval.
Measured: 2 years
To determine the rate of failure to progress to surgery due to disease progression during neoadjuvant radiotherapy, and conversely the proportion of patients who do receive surgical resection
The rate of failure to progress to surgery due to disease progression during neoadjuvant radiotherapy will be presented with 95% Confidence Interval. The rate of progression to surgery will be presented with 95% CI. The proportion of patients who receive surgical resection overall will be presented with 95% Confidence Interval.
Measured: 2 years
To document the proportion of peri-operative complications
The proportion of patients with peri-operative complications will be presented with 95% Confidence Interval.
Measured: 2 years
To evaluate the impact of treatment on OS, overall and by resectability (whether resectable or borderline resectable)
The Kaplan-Meier method will be used to estimate OS. This will be expressed as median survival with 95% Confidence Interval and will be analysed after patients have been followed for two years after completion of study treatment. The Log-rank test will be used to compare differences in survival between resectable and borderline resectable patients.
Measured: 2 years
To evaluate the impact of treatment on PFS, overall and by resectability (whether resectable or borderline resectable)
The Kaplan-Meier method will be used to estimate PFS. This will be expressed as median survival with 95% Confidence Interval and will be analysed after patients have been followed for two years after completion of study treatment. The Log-rank test will be used to compare differences in survival between resectable and borderline resectable patients.
Measured: 2 years
To evaluate tumour response on surgically resected patients using resected specimens
The proportion of surgically resected patients receiving at least 14 fractions of RT with tumour response using the resected specimens will be presented with 95% Confidence Interval.
Measured: 2 years
To evaluate Quality of Life
The mean (and standard deviation) of the overall and domain specific European Organisation for Research and Treatment for Cancer (EORTC) Quality Life Questionnaire (QLQ) C30 scores at each time point will be reported (pre-chemotherapy, pre-RT, pre-surgery, 6-, 12- and 24-months post RT).
The EORTC QLQ C30 questionnaire has five functioning subscale scores and nine symptoms subscale scores.
Minimum value = 0; Max value = 100 Function Scales: Higher numbers mean better function Symptom Scale: Higher numbers mean more symptoms
Measured: 2 years
To evaluate Quality of Life
The mean (and standard deviation) of the overall and domain specific European Organisation for Research and Treatment for Cancer (EORTC) Quality Life Questionnaire (QLQ) PAN 26 scores at each time point will be reported (pre-chemotherapy, pre-RT, pre-surgery, 6-, 12- and 24-months post RT).
The EOTRC QLQ PAN 26 questionnaire is a tumour specific quality of life questionnaire for patients with pancreatic cancer.
Minimum value = 0; Max value = 100 Function Scales: Higher numbers mean better function Symptom Scale: Higher numbers mean more symptoms
Measured: 2 years
To evaluate the incidence of late GI toxicities in patients who do not undergo surgical resection
The incidence of late toxicity at 6-, 12- and 24-months post-RT, in patients who do not undergo surgical resection, will be calculated, summarised and presented in tabular format with proportions plus 95% Confidence Interval where appropriate. Toxicities of ≥ Grade 2 are of specific interest. Counts and frequencies will be provided for the worst grade AE experienced
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start30 Jan 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024824
- Sponsor's protocol ID
- CTRIAL-IE 17-12
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DP-IMRT Pancreas: A Non-randomised Phase I/II Study of Dose-escalated Hypofractionated Dose-Painted Intensity Modulated Radiotherapy (DPIMRT) in Resectable/Borderline Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06024824
- Acronym / sponsor ID
- CTRIAL-IE 17-12
- Conditions
- Pancreatic Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 6 Sep 2023 (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.
This is a prospective non-randomised Phase I/II Radiotherapy (RT) study with patients recruited to escalated dose cohorts. Patients with resectable or borderline resectable (per the National Comprehensive Cancer Network (NCCN) criteria) pancreatic adenocarcinoma will receive dose-escalated hypofractionated DP-IMRT via Intensity Modulated Radiotherapy (IMRT) / Volume Modulated Arc Therapy (VMAT).
Detailed description
The study treatment is radiotherapy. Different doses of radiotherapy will be given to patients. The first group of patients will receive the lowest dose (dose level 1) (this is the dose delivered to patients as standard of care). If the treatment does not cause serious side effects, it will be given to the next group of patients enrolled at a higher dose (dose level 2) (this is called 'dose escalation'). If this higher dose of treatment does not cause serious side effects, the next group of patients will receive a higher dose (dose level 3). The doses will continue to increase for every group of patients, as long as no serious side effects occur. If this happens, the study is halted. Once the optimum dose level has been reached, a larger cohort of patients will all receive this dose.
Phase I: A 3+3 dose escalation design is proposed to determine the maximum tolerated dose (MTD) defined by the number of radiotherapy-related ≥ Grade 3 acute toxicities assessed up to 4 weeks post RT. Three cohorts of between 3 and 6 patients at each dose level will be accrued in order to establish the MTD (minimum of 6, maximum of 18 patients). The MTD defined in Phase I will be the dose which will be used in Phase II of the trial. Phase II: 49 patients: Once the MTD is established, patients will continue to be recruited at that dose level up to a total of 49 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation; IMRT | Experimental | Radiation: Dose-Painted Intensity Modulated RadiotherapyFifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT/ VMAT. Cohort 1 (n = 3-6) Single PTV 40.05 Gy/15#, homogenous dose* Cohort 2 (n = 3-6) High Risk PTV 45 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions* Cohort 3 (n = 3-6) High risk PTV 48 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions * Progression to the next dose in successive cohorts depends on the number of patients experiencing DLTs within 4 weeks post-RT treatment in each patient cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained prior to any study-related procedures
- Age ≥18 years
- ECOG (European Cooperative Oncology Group) performance status (PS) 0-2
- Resectable or borderline resectable per National Comprehensive Cancer Network (NCCN) criteria (see Appendix H)
- Patients with histologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC), with the following staging: cT1N0-2, cT2N0-2, cT3N0-2 [American Joint Committee on Cancer (AJCC) 8th edition] (see Appendix C) who are planned for pre-operative systemic chemo-radiotherapy
Key exclusion criteria (6 listed)
- Previous thoracic or abdominal or pelvic radiation therapy (RT)
- Previous treatment for bilirubin regression, other than stenting
- Known co-existing or prior malignancy within the last 5 years (except for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin) which is likely to interfere with treatment or assessment of outcomes
- Syndromes or conditions associated with increased radiosensitivity
- Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes, or psychiatric illness/ social situations that would limit compliance with study requirements
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 |
|---|---|---|
| Dose-Painted Intensity Modulated RadiotherapyFifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT/ VMAT. Cohort 1 (n = 3-6) Single PTV 40.05 Gy/15#, homogenous dose. Cohort 2 (n = 3-6) High Risk PTV 45 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions. Cohort 3 (n = 3-6) High risk PTV 48 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions. | Radiation | Radiation; IMRT |
Primary outcome
Phase 1 - to establish the MTD in a dose-escalated and hypofractionated RT regime delivered via IMRT/VMAT by the number of DLTs
Time frame: 4 weeks
To establish the MTD in a dose-escalated and hypofractionated RT regime delivered via IMRT/VMAT by the number of DLTs, and the rate of patient withdrawal from trial treatment due to DLTs. Analysis will be performed for each cohort after all patients have been assessed for their 4-week post RT assessment.
Phase 2 - to determine the frequency and severity of DLTs due to AE/Toxicity meeting definition of DLT at 4 weeks post RT
Time frame: 4 weeks
The rate of DLTs up to 4 weeks post RT will be calculated. This proportion along with the 90% confidence intervals will be reported.
Phase 2 - to determine the rate of patient withdrawal from trial treatment due to AE/Toxicity meeting definition of DLT at 4 weeks post RT
Time frame: 4 weeks
The rate of withdrawal from trial treatment of patients due to DLTs will be calculated. This proportion along with the 90% Confidence Interval will be reported. Other toxicity data including SAEs will be summarised and presented in tabular format with proportions plus 95% Confidence Interval where appropriate.
9 secondary outcomes
To quantify the percentage of histologically proven R0 resections in the trial patient group (R0 to be defined as a minimal clearance of at least1 mm).
Time frame: 2 years
To determine the rate of failure to progress to surgery due to disease progression during neoadjuvant radiotherapy, and conversely the proportion of patients who do receive surgical resection
Time frame: 2 years
To document the proportion of peri-operative complications
Time frame: 2 years
To evaluate the impact of treatment on OS, overall and by resectability (whether resectable or borderline resectable)
Time frame: 2 years
To evaluate the impact of treatment on PFS, overall and by resectability (whether resectable or borderline resectable)
Time frame: 2 years
To evaluate tumour response on surgically resected patients using resected specimens
Time frame: 2 years
To evaluate Quality of Life
Time frame: 2 years
To evaluate Quality of Life
Time frame: 2 years
To evaluate the incidence of late GI toxicities in patients who do not undergo surgical resection
Time frame: 2 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 20 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dose-Painted Intensity Modulated Radiotherapy in people with Pancreatic Adenocarcinoma, run by Cancer Trials Ireland at 2 sites in Ireland.
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 7 inclusion and 6 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cancer Trials Ireland (+35316677211, info@cancertrials.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 - to establish the MTD in a dose-escalated and hypofractionated RT regime delivered via IMRT/VMAT by the number of DLTs (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 20 Jul 2025.