Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (SHAPER) (SHAPER)
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|ClinicalTrials.gov Identifier: NCT04106856|
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : May 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Borderline Resectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Ductal Adenocarcinoma Locally Advanced Unresectable Pancreatic Adenocarcinoma Stage II Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8||Radiation: Hypofractionated Radiation Therapy Drug: Losartan Drug: Losartan Potassium Other: Quality-of-Life Assessment Other: Questionnaire Administration||Phase 1|
I. To assess the safety of losartan potassium (losartan) in combination with hypofractionated radiation treatment for patients with stable or locally progressive pancreatic ductal adenocarcinoma (PDAC) after induction chemotherapy.
I. To assess the safety of losartan in combination with HRT for patients with stable or locally progressive PDAC after induction chemotherapy.
II. To assess the efficacy of losartan in combination with HRT for patients with stable or locally progressive PDAC after induction chemotherapy.
III. To assess the rate of hypotensive adverse events grade >= 3.
I. To assess patient reported quality of life.
Beginning day 1, patients receive losartan potassium orally (PO) once daily (QD). Beginning day 14, patients also undergo hypofractionated radiation therapy over 15 fractions 5 days a week for up to 3 weeks. Patients continue to receive losartan potassium PO QD during radiation therapy and for 28 days after completion of radiation therapy.
After completion of study treatment, patients are followed up at 28 and 84 days, every 3 months for 12 months, and then every 6 months for up to 36 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SHAPER: A Phase 1 Study of Losartan and Hypofractionated Radiation Therapy After Induction Chemotherapy for Borderline Resectable or Locally Advanced Pancreatic Cancer|
|Actual Study Start Date :||August 8, 2019|
|Estimated Primary Completion Date :||August 8, 2024|
|Estimated Study Completion Date :||August 8, 2025|
Experimental: Treatment (losartan, hypofractionated radiation therapy)
Beginning on day 1, patients receive losartan potassium PO QD. Beginning day 14, patients also undergo hypofractionated radiation therapy over 15 fractions 5 days a week for up to 3 weeks. Patients continue to receive losartan potassium PO QD during radiation therapy and for 28 days after completion of radiation therapy. Patients may begin additional anti-cancer therapy per investigator discretion after the last dose of HRT. Losartan can be given concurrently with additional therapy and Losartan dosing can continue until 28 days after last dose of HRT, regardless of when additional therapy is started.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Drug: Losartan Potassium
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Grade 3 or higher gastrointestinal toxicity rate [ Time Frame: Up to 3 months (84 days) after completion of radiation therapy ]Will be graded according to Common Terminology Criteria for Adverse Events version (v) 5.0. The proportion of subjects that experience this endpoint will be tabulated along with an exact 90% binomial confidence interval (Clopper-Pearson).
- Frequency of adverse events [ Time Frame: Up to 3 months (84 days) after completion of radiation therapy ]Will be graded according to Common Terminology Criteria for Adverse Events version (v) 5.0.
- Response rate (clinical and/or pathologic partial response [PR] and complete response [CR]) [ Time Frame: Up to 36 months post-treatment ]Will be described using Response Evaluation Criteria in Solid Tumors v1.1. The proportion of subjects with a PR and CR will be reported along with exact binomial confidence intervals (Clopper-Pearson).
- Progressive free survival (PFS) [ Time Frame: From the time of enrollment until disease progression or death (any cause), assessed up to 36 months post-treatment ]Kaplan-Meier methods will be used to report PFS.
- Overall survival (OS) [ Time Frame: From the patient?s first dose of study drug to death due to any cause, assessed up to 36 months post-treatment ]Kaplan-Meier methods will be used to report OS.
- Number patients that require a medical intervention or hospitalization due to hypotension [ Time Frame: Up to 36 months post-treatment ]Will be analyzed descriptively.
- Patient reported quality of life assessment- review of symptoms and how they interfere in life [ Time Frame: At study entry, during the final week of radiation therapy, and at each follow up visit ]Will be assessed using MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI).
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): NCT04106856
|Contact: Mitchell Sheafirstname.lastname@example.org|
|United States, Utah|
|Huntsman Cancer Institute/University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Shane Lloyd 801-585-0255 email@example.com|
|Principal Investigator: Shane Lloyd|
|Principal Investigator:||Shane Lloyd||Huntsman Cancer Institute/ University of Utah|