Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)
ConditionPancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Trials Ireland
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Dose-Painted Intensity Modulated Radiotherapy
RadiationFifteen 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.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Radiation; IMRTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4 weeks2
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.
Time frame
4 weeks3
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.
Time frame
4 weeksSecondary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 years3
To document the proportion of peri-operative complications
The proportion of patients with peri-operative complications will be presented with 95% Confidence Interval.
Time frame
2 years4
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.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov