Magnetic Resonance (MR) Guided, Dose-Escalated Radiation Therapy (RT) + Chemotherapy 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: NCT01972919|
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Pancreatic Cancer||Radiation: Radiation Therapy Drug: Concurrent chemotherapy (Gemcitabine, Capecitabine)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-metastatic Pancreatic Cancer|
|Actual Study Start Date :||December 10, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2023|
Experimental: Radiation therapy plus chemotherapy
MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine.
Radiation: Radiation Therapy
Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction.
Other Name: Dose escalation radiation therapy
Drug: Concurrent chemotherapy (Gemcitabine, Capecitabine)
Gemcitabine 400mg/m2 IV weekly x 6 doses. Capecitabine 825 mg/m^2 by mouth twice daily Monday-Friday on days of radiation use 500mg tablets.
- Efficacy of dose escalation [ Time Frame: Baseline and 1 year ]This measure is the change from baseline of gross tumor volume for participants achieving a complete response (CR) or partial response (PR) or maintaining stable disease (SD) by RECIST 1.1 criteria.
- Radiographic response [ Time Frame: Baseline and 1 year ]Number of participants treated with the proposed dose escalation achieving CR, PR, or SD measured by RECIST 1.1 criteria from magnetic resonance imaging (MRI), positron emission tomography (PET) or computed tomography (SC) scans.
- Serum Cancer Antigen 19-9 (CA19-9) [ Time Frame: Baseline and 1 year ]This measure will be the mean serum activity of CA19-9 in units/mL.
- Serum Carcinoembryonic Antigen (CEA) [ Time Frame: Baseline and 1 year ]This measure will be the mean serum concentration of CEA in ng/mL.
- Radiation induced toxicity [ Time Frame: 3 months post treatment ]This measure will be the number of subjects experiencing a serious adverse event or grade three or higher non-serious adverse event by CTCAE v4.03 criteria that is definitely, likely, or possibly attributable to the radiation therapy.
- SMAD 4 expression [ Time Frame: 4 years ]This measure will be the number of participants whose tumor biopsy is positive for the presence of SMAD 4 protein.
- Overall Survival [ Time Frame: 1 and 2 years ]This measure will be the number of subjects alive at one and two years following the end of radiation treatment.
- Progression Free Survival [ Time Frame: 1 and 2 years ]This measure will be the number of subjects achieving a CR or PR or maintaining SD by RECIST 1.1 criteria one and two years following the end of radiation treatment.
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): NCT01972919
|Contact: Cancer Center Clinical Trials Office||1-800-680-0505 ext firstname.lastname@example.org|
|Principal Investigator:||Beth Erickson, MD||Froedtert & The Medical College of Wisconsin|