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Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452357
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:
Standard chemoradiation, followed by surgery are standard treatment plan for patients suffering from pancreatic adenocarcinoma. Due to damage to the surrounding healthy tissue caused by standard radiation, this study uses a new type of radiation plan- pulsed low-dose rate (PLDR) radiation , in combination with chemotherapeutic drug, gemcitabine, given weekly along with the radiation.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: PLDR Not Applicable

Detailed Description:

Radiation, combined with radiosensitizing chemotherapies, is often used preoperatively for borderline resectable cases with the intent of facilitating a curative surgical intervention. This includes providing margin adjacent to un-resectable vessels and sterilizing regional lymph nodes. Unfortunately, due to the radiosensitivity of adjacent small bowel and stomach, the total dose of radiation used is modest due to the risk of toxicities associated with higher doses. Pulsed low-dose-rate (PLDR) radiation improves the safety of radiation through breaking it up into small pulses. This increases the repair of DNA damage in normal tissues while remaining effective in cancer cells. Multiple prior studies have shown PLDR to be safe in the setting of re-irradiation, where additional radiation with conventional techniques is associated with severe toxicity.

PLDR radiation will be given in 2 doses to 6 patients at each dose level:

Dose level 1: 56 Gy- given over 6 weeks Dose level 2: 66 Gy- given over 7 weeks Standard chemotherapeutic drug, gemcitabine, will be administered once a week for the duration of radiation.

This treatment will be followed by standard surgery to remove the cancer after consultation with a surgeon.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RT-155: Utilizing Pulsed Low-dose-rate (PLDR) Radiation to Prevent de Novo Stromal Activation; a Neoadjuvant Pancreatic Adenocarcinoma Phase I Trial
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PLDR Chemoradiation

Patients will receive pulse-low-dose rate radiation, along with gemcitabine chemotherapy.

6 patients each will be accrued at two dose levels. PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows: Dose level 1: 56 Gy; Dose level 2: 66 Gy

Radiation: PLDR

PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows:

Dose level 1: 56 Gy; Dose level 2: 66 Gy Drug: Gemcitabine





Primary Outcome Measures :
  1. Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation. [ Time Frame: 11 weeks ]
    umber of participants with Grade 3 toxicity related to the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma.
  • Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection. This includes the following:

    • Any involvement (defined as loss of fat plane on contrast CT) of any of the following vessels*:

      • Common hepatic artery
      • Superior mesenteric artery
      • Celiac axis
      • Superior mesenteric vein
      • Portal vein
      • Aorta

        • These criteria will be judged by the operating surgeon in conjunction with a radiologist prior to enrollment.
    • Poor performance status not immediately conducive to radical surgery
    • Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation
  • Patients must have evaluable disease as measured by RECIST 1.1 criteria.
  • Planned surgical resection at the time of enrollment (may be initially staged as resectable, borderline resectable, or locally-advanced/unresectable).
  • Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
  • Adequate bone marrow, hepatic, renal function.

    • ANC ³ 1,500/ml and PLT ³ 100,000/ml
    • Bilirubin less than 1.5 ULN
    • AST and ALT < 3X ULN
    • Serum Creatinine <1.5X ULN
  • Prior chemotherapy allowed, but not mandatory. Patients who have undergone chemotherapy prior to participating in this study must have had a 2 week washout period at the time of signing the consent form.
  • Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration. Postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed. Please refer to section 6.4 for additional detail.
  • Age > 18 years
  • Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.

Exclusion Criteria:

  • Radiological or cytologically confirmed metastatic disease
  • Patients who have had any prior therapy for pancreatic cancer, except chemotherapy (see 6.1.7)
  • Concurrent non-study chemotherapy or biologic therapy
  • A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
  • Scleroderma or active connective tissue disease
  • Active inflammatory bowel disease
  • Serious, active infections requiring treatment with IV antibiotics
  • Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452357


Contacts
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Contact: Joshua Meyer, MD 215-728-2667 Joshua.Meyer@fccc.edu
Contact: Meghann Hainsworth 215-728-5506 Meghann.Hainsworth@fccc.edu

Locations
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United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Joshua Meyer, MD    215-728-2667    Joshua.Meyer@fccc.edu   
Contact: Meghann Hainsworth    215-728-5506    Meghann.Hainsworth@fccc.edu   
Sponsors and Collaborators
Fox Chase Cancer Center
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT04452357    
Other Study ID Numbers: RT-155
18-1085 ( Other Identifier: Fox Chase cancer Center )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases