Pancreatic Adenocarcinoma Clinical Trial
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).
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05305001 -
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
|
||
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Completed |
NCT01959672 -
Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT03673423 -
Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
|
||
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
| Not yet recruiting |
NCT06026943 -
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer
|
N/A | |
| Completed |
NCT03054987 -
Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction
|
N/A | |
| Terminated |
NCT02345460 -
Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
|
Phase 2 | |
| Recruiting |
NCT02072616 -
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
|
Phase 3 | |
| Completed |
NCT02174887 -
Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer
|
Phase 1 | |
| Recruiting |
NCT03703063 -
Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer
|
Phase 1 | |
| Terminated |
NCT04077372 -
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
|
N/A | |
| Recruiting |
NCT03073785 -
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT03665441 -
Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
|
Phase 3 | |
| Recruiting |
NCT04627246 -
Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT06217666 -
Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
|
Phase 1 | |
| Recruiting |
NCT05585320 -
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT04119362 -
PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
|
||
| Completed |
NCT03105921 -
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
|
N/A |