A Phase 1 interventional study of 10 Gy Low-KV IORT and 15 Gy Low-KV IORT in Pancreas Cancer, sponsored by Loyola University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Loyola University · Phase 1, Interventional, and Treatment
Currently, for patients with pancreatic cancer the standard treatment is surgery followed by chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery and treat the area of the tumor with intraoperative radiotherapy in one procedure. Intraoperative radiation delivers low energy x-rays to a targeted area during the time of tumor removal.
The purpose of this study is to learn about both the good and bad effects of adding intraoperative radiation therapy. Another goal is to determine and compare the quality of life before and after the procedure. We will also monitor the effect of the therapy on the cancer lesion and any complications that may result.
The purpose of this study is to determine safety of low kilovoltage radiotherapy delivery of a focused dose of radiation to the areas at high risk for locoregional recurrence following pancreaticoduodenectomy. This surgery is currently the only potentially curative approach for patients with pancreatic cancer. Unfortunately, following surgery alone >50% of patients will have a local recurrence of disease [5]. Local control will become increasingly important as chemotherapy regimens continue to improve the distant metastases-free survival. Intraoperative radiation therapy allows direct access to the tumor bed and areas of concern while allowing displacement and shielding of normal tissue and organs at risk of radiation toxicity.
Study Objectives The primary objective is to determine the maximum tolerated dose (MTD) for low kilovoltage (kV) intraoperative radiotherapy (IORT)
The secondary objectives are:
To develop acute and chronic toxicity profiles for this treatment modality
To determine the feasibility of including low-kV IORT in the treatment of pancreatic cancer
To evaluate the following physics and delivery parameters: treatment prescription dose, depth of treatment, applicator type, and treatment time.
To measure patient's quality of life (QOL) before and after treatment, including change in pain level and fatigue level.
To describe the disease specific outcomes of local regional control, progression free-survival, distant metastasis free-survival, disease free-survival and overall survival associated with low-kV IORT following pancreaticoduodenectomy.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 12 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
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Laboratory Test Result Leukocytes ≥3000/mm3 Absolute Neutrophil Count (ANC) ≥1500/mm3 Platelets ≥100,000/mm3 Total Bilirubin ≤1.4 mg/dL AST(SGOT),ALT(SPGT) ≤2.5 x institutional upper limit of normal Serum creatinine ≤1.4 mg/dL INR ≤1.5 BUN \< 20 mg/dL Albumin ≥3.5 g/dL
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria:
10 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
Radiation: 10 Gy Low-KV IORT
15 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
Radiation: 15 Gy Low-KV IORT
20 GY Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized.
Radiation: 20 GY Low-KV IORT
: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized.
Maximum Tolerated Dose
Maximum Tolerated Dose as defined by Radiation-related acute Grade 3-5 toxicity in greater than or equal to 2 patients out of 6 patients at any dose level
Time frame: 52 weeks
QOL surveys
. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQC30) 30 item questionnaire to evaluate cancer patients' physical, psychological, and social functioning. Patients are asked to rate symptoms on a YES or NO scale; a 4 point scale ranging from 1 (Not at all) to 4 (Very much); and a 7 point scale ranging 1 (Very poor) to 7 (Excellent)
Time frame: 52 weeks
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Loyola University