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

  • STATUS
    Recruiting
  • participants needed
    12
  • sponsor
    Fox Chase Cancer Center
Updated on 19 February 2024
cancer
gemcitabine
adenocarcinoma
chemoradiotherapy
pancreatic adenocarcinoma
metastatic pancreatic cancer
celiac
kidney function tests
celiac disease

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.

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.

Details
Condition Pancreatic Cancer, Pancreatic Cancer, Pancreatic disorder, Neoplasm of unspecified nature of digestive system
Age 18-100 years
Treatment PLDR
Clinical Study IdentifierNCT04452357
SponsorFox Chase Cancer Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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 1,500/ml and PLT 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.