Magnetic Resonance (MR) Guided, Dose-Escalated Radiation Therapy (RT) + Chemotherapy in Pancreatic Cancer

STATUS

Recruiting
End date

May 18, 2024
participants needed

23
sponsor

Medical College of Wisconsin

Send

Updated on 7 October 2022

See if I qualify

ct scan

cancer

metastasis

neutrophil count

gemcitabine

Summary

This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this chemotherapy course.

Description

In this study the investigators want to find out more about the efficacy of giving higher doses of radiation with concurrent chemotherapy in controlling unresectable pancreas cancers than are used in either the pre-operative or post-operative setting. The investigators will assess acute and late side effects (problems and symptoms) of radiation therapy given at these higher doses of radiation (dose escalated) following full dose chemotherapy given before the radiation and with concurrent chemotherapy for pancreas cancer. Radiation therapy is given in higher doses that are limited by the proximity of normal organs to the radiation dose distribution to improve the likelihood of controlling the tumor in the pancreas while minimizing the risk of radiation injury to these organs. There are two chemotherapy drugs, Capecitabine is an oral drug taken twice per day on the same day that radiation therapy is given and Gemcitabine is an intravenous drug given once per week, during radiation therapy. Everyone in this study will have already received chemotherapy alone first. Everyone in this study will receive radiation therapy and concurrent chemotherapy.

Details

Condition	Unresectable Pancreatic Cancer
Treatment	radiation therapy, Concurrent chemotherapy (Gemcitabine, Capecitabine)
Clinical Study Identifier	NCT01972919
Sponsor	Medical College of Wisconsin
Last Modified on	7 October 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Pathologically confirmed (histologic or cytologic), locally advanced, adenocarcinoma of the pancreas; patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability
	Participants with and without regional adenopathy are eligible
	No distant metastases, based upon the following minimum diagnostic workup
	History/physical examination, including collection of weight and vital signs, within 28 days prior to study entry
	Abdominal/pelvic CT scan with IV contrast within 21 days prior to study entry
	Chest CT scan, or X-ray within 21 days prior to study entry
	Abdominal/pelvic MR prior to radiation with perfusion and diffusion- weighted sequences and MR and CT sim for radiation planning Pet scan within 21 days prior to study entry, Functional renal study
	Zubrod performance status 0-1 within 1 week of study entry
	Age ≥ 18
	Hematology and cancer antigen (CA) 19-9 / carcinoembryonic antigen (CEA) within 14 days prior to study entry, as follows
	Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
	Platelets ≥ 100,000 cells/mm^3
	Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
	Serum creatinine ≤ 1.5 mg/dl
	Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN)
	Total bilirubin < 3.0 mg/dL
	Alkaline phosphatase < 3 x ULN
	Fasting blood glucose < 160 mg/dl
	Negative serum pregnancy test (if applicable) within 14 days prior to study entry
	Ability to swallow oral medications
	Participants must have had at least 4 months of prior systemic chemotherapy
	Participants must provide study specific informed consent prior to study entry
	Women of childbearing potential and male participants who are sexually active must practice adequate contraception
Exclusion Criteria
	Distant metastatic disease, second malignancy or peritoneal seeding
	Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
	Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
	Any major surgery within 28 days prior to study entry
	Severe, active co-morbidity, defined as follows
	Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
	Transmural myocardial infarction within 3 months prior to study entry
	Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
	Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
	Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function
	Any unresolved bowel or bile duct obstruction
	Major resection of the stomach or small bowel that could affect the absorption of capecitabine
	Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition
	Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women, for 3 months after the last study drug administration
	Women who are lactating at the time of registration and who plan to be lactating through 3 months after the last study drug administration
	Prior allergic reaction to capecitabine or gemcitabine
	Inability to undergo an MR of the abdomen/pelvis
	Participation in another clinical treatment trial while on study

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

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

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

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

Learn more

Step 3 Enroll in the clinical study

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

Step 4 Get your study results

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

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.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

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!

Enter the passcode

The passcode will expire in None.

Magnetic Resonance (MR) Guided, Dose-Escalated Radiation Therapy (RT) + Chemotherapy in Pancreatic Cancer