NCT02599662

Intraoperative Radiation Therapy for Resectable Pancreas Cancer

Phase I Study of Low Kilovoltage Intraoperative Radiation for Patients With Resectable Pancreatic Adenocarcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
RADIATION	10 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.
RADIATION	15 Gy Low-KV IORT	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	20 GY Low-KV IORT	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2015-11-06
• Last updated: 2020-06-04

Locations

1 site across 1 country: United States