Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatm… (NCT03523312) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatment in Patients With Locally Advanced Pancreatic Cancer
United States47 participantsStarted 2018-04-30
Plain-language summary
This study is being done to test whether receiving a dose of radiation that is higher than the standard dose, in combination with chemotherapy, improves the chance of becoming a candidate for surgery and improves the chance of extending the patient's life.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
* Locally advanced, unresectable pancreatic cancer defined on post-induction chemotherapy CT as having tumor involvement of \>180° (\> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
* No evidence of distant metastasis either prior to or after induction chemotherapy.
* Completion of at least 3 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, within 6 weeks of enrollment.
* For patients currently receiving investigational agents, a washout of at least 2 weeks or 5 half-lives of experimental agent are required prior to the start of RT.
* Age ≥18 years.
* KPS 70-100.
* Patients must have acceptable organ and marrow function as defined below:
* Leukocytes \>3,000/µL
* Absolute neutrophil count \>1,500/µL
* Platelets \>75,000/µL
* Total bilirubin Within 2 x upper limit of normal
* AST (SGOT)/ALT (SGPT) \<2.5 x institutional upper limit of normal Creatinine Within 1.5 x upper limit of normal, OR Creatinine clearance \>60 mL/min for patients with creatinine levels above institutional normal
* Any systemic therapy associated toxicity should be Grade 1 or less
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients who have borderline resectab…
What they're measuring
1
The proportion of patients who undergo definitive surgery