MR Guided Dose Escalated RT + Concurrent Chemotherapy in Unresectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01972919|
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : November 12, 2018
|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|
|Study Start Date :||March 2016|
|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 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 1m2 IV weekly x 6 doses. Capecitabine 825 mg/mm2 po bid Monday-Friday on days of radiation use 500mg tablets.
- To evaluate the efficacy of dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction for unresectable pancreatic cancer. [ Time Frame: One year from the start of treatment ]To evaluate acute and late (> 3 months post treatment) radiation induced toxicities.
- To evaluate radiographic and biochemical response for patients treated with the proposed dose escalation. [ Time Frame: One year from the start of treatment ]To evaluate radiographic and biochemical response for patients treated with the proposed dose escalation using pre- and post- treatment MR and PET scanning in addition to routine surveillance CT scans and CEA/ CA 19-9 levels.
- Radiation induced toxicities [ Time Frame: > 3 months post treatment ]To evaluate acute (> 3 months post treatment) and late radiation induced toxicities.
- SMAD 4 expression [ Time Frame: 4 years ]SMAD 4 expression vs pattern of relapse
- Survival rates [ Time Frame: 7 years ]1 & 2 year overall survival, median survival and progression survival rates.
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 email@example.com|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Beth Erickson, MD 414-805-4460 firstname.lastname@example.org|
|Contact 1-866-680-0505 ext 8900 email@example.com|
|Principal Investigator: Beth Erickson, MD|
|Principal Investigator:||Beth Erickson, MD||Froedtert & The Medical College of Wisconsin|