Peritoneal (Metastatic) CancerPhase 2RANDY 1ANCT07856914
Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer
A Phase 2 study testing Paricalcitol and pirfenidone in people with Peritoneal (Metastatic) Cancer and Peritoneal Carcinoma, run by Patrick Wagner, MD, FACS.
Trial summary
The goal of this clinical trial is to learn if paricalcitol or pirfenidone can help make tumors removable by surgery in adults with peritoneal cancer who are currently unable to have their tumor removed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritoneal (Metastatic) Cancer, Peritoneal Carcinoma, Peritoneal Carcinosis
- What is being tested?
- Paricalcitol and pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, age 18 to <81 years at the time of consent
- Biopsy-proven peritoneal carcinomatosis
- Documented receipt of at least three months of standard systemic chemotherapy prior to initiation, with persistent disease
- ECOG Performance Status of 0 or 1
- Adequate organ function within 14 days prior to anti-fibrotic initiation
- Negative serum pregnancy test for women of childbearing potential (WOCBP) within 7 days prior to initiation
- Able to understand and provide written informed consent
- Willingness and ability to comply with all study procedures
Who cannot join
- Patients deemed eligible for definitive cytoreductive surgery
- Current or recent (within 30 days) use of paricalcitol, pirfenidone, or Vitamin D supplementation above USDA-recommended daily dosage
- Known allergy or medical contraindication to study drugs
- Hypersensitivity to any of the study drugs or to any ingredient in the formulation
- Receipt of any investigational drug within 30 days prior to initiation
- Active pregnancy or lactation
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- Active smoking
- Active brain metastases
- Elevated Vitamin D level (>2x upper limit of normal)
- Significant comorbidities including abnormal calcium/phosphate, history of serious drug-induced liver injury, severe cardiac conditions, patients with or predisposed to cardiac arrhythmias, or uncontrolled hypertension
- Concomitant medications that, after review by the study pharmacist(s) and potential dose modification in accordance with prescribing guidelines, still pose an unmanageable drug-drug interaction or unacceptable safety risk with either study drug
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Phase II Bayesian Pick-the-Winner Clinical Trial Investigating the Efficacy of Fibrosis-Modulating Agents (Paricalcitol and Pirfenidone) in Improving Surgical Resectability in Patients With Peritoneal Carcinomatosis Ineligible for Definitive Cytoreduction (Randy 1A)
The goal of this clinical trial is to learn if paricalcitol or pirfenidone can help make tumors removable by surgery in adults with peritoneal cancer who are currently unable to have their tumor removed.
The study aims to answer are whether paricalcitol or pirfenidone improve tumor response and tissue healing after 12 weeks of treatment, and which of these two drugs is more effective at helping participants become eligible for surgery. Researchers will compare paricalcitol to pirfenidone to see which drug works better and has a manageable safety profile.
Participants will take either paricalcitol or pirfenidone by mouth every day for 12 weeks while continuing their standard chemotherapy, visit the clinic regularly for checkups and lab tests, keep a daily diary to track their study medication, and undergo a surgical re-evaluation after treatment to see if their tumor can be removed.
Read the detailed description
This is a single-center, randomized Phase II clinical trial designed to investigate the efficacy of repurposing fibrosis-modulating agents to improve surgical resectability in patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is characterized by a challenging tumor microenvironment (TME) featuring extensive fibrosis and a high density of cancer-associated fibroblasts (CAFs). These elements create a dense desmoplastic barrier that impedes drug penetration, limits therapeutic efficacy, and frequently renders patients ineligible for definitive surgical cytoreduction.
To overcome these barriers, the trial evaluates two distinct anti-fibrotic agents: paricalcitol, a synthetic Vitamin D receptor agonist that promotes CAF quiescence and stromal remodeling, and pirfenidone, an oral anti-fibrotic agent that inhibits fibrosis by downregulating the TGF-β signaling pathway and collagen synthesis. Eligible participants are randomized in a 1:1 ratio to receive a 12-week course of either oral paricalcitol (2 mcg daily, titratable) or oral pirfenidone (titrated to 801 mg three times daily with food), administered concurrently with their ongoing standard systemic chemotherapy.
- Conditions
- Peritoneal (Metastatic) Cancer, Peritoneal Carcinoma, Peritoneal Carcinosis, Peritoneal Cancer, Peritoneal Carcinomatosis, Peritoneal Carcinomatosis From Colorectal or Ovarian Origin
- Being tested
- Paricalcitol, pirfenidone
- Keywords
- Peritoneal carcinomatosis, Peritoneal cancer, Peritoneal metastases, Intra-abdominal malignancies, Advanced abdominal cancer with fibrosis, Paricalcitol, Pirfenidone, Vitamin D analog, Anti-fibrotic therapy, Anti-fibrotic agents, Repurposed drugs in oncology, Surgical resectability, Cytoreductive surgery, Tumor cytoreduction, Tumor microenvironment, Cancer-associated fibroblasts
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Oral, 2 mcg once daily for 12 weeks
pirfenidoneDrug
Oral, titrated up to 801 mg three times daily (total daily dose: 2403 mg/day) with food for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol Arm | Experimental | Participants receive oral paricalcitol once daily for 12 weeks concurrently with standard systemic chemotherapy. Receives: Drug: Paricalcitol |
| Pirfenidone Arm | Experimental | Participants receive oral pirfenidone three times daily for 12 weeks (with initial dose titration) concurrently with standard systemic chemotherapy. Receives: Drug: pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paricalcitol Efficacy
Proportion of patients achieving a clinicopathologic response (CPR)
Measured: 12 weeks from treatment initiation
Pirfenidone Efficacy
Proportion of patients achieving a clinicopathologic response (CPR)
Measured: 12 weeks from treatment initiation
Secondary outcomes (18)
Severity of Treatment-Emergent Adverse Events for Paricalcitol [Safety]
Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome.
Measured: 16 weeks from treatment initiation
Severity of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome
Measured: 16 weeks from treatment initiation
Incidence of Treatment-Emergent Adverse Events for Paricalcitol [Safety
Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 16 weeks from treatment initiation
Incidence of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 16 weeks from treatment initiation
Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Paricalcitol [Tolerability]
Assessment of patient-reported quality of life outcomes using the SF-20 questionnaire. Each subscale ranges from a minimum score of 0 to a maximum score of 100, where higher scores indicate a better health-related quality of life outcome.
Measured: 12 weeks
Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Pirfenidone [Tolerability]
Assessment of patient-reported quality of life outcomes using the SF-20 questionnaire. Each subscale ranges from a minimum score of 0 to a maximum score of 100, where higher scores indicate a better health-related quality of life outcome.
Measured: 12 weeks
Treatment Adherence Evaluated via Study Drug Diaries for Paricalcitol [Feasibility]
Percentage of total prescribed doses taken based on study drug diaries (number of doses taken divided by total expected doses over 12 weeks).
Measured: 12 weeks
Treatment Adherence Evaluated via Study Drug Diaries for Pirfenidone [Feasibility]
Percentage of total prescribed doses taken based on study drug diaries (number of doses taken divided by total expected doses over 12 weeks).
Measured: 12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Paricalcitol [Efficacy]
Evaluation of molecular correlates of treatment response using research blood samples collected at baseline and post-treatment.
Measured: 12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Pirfenidone [Efficacy]
Evaluation of molecular correlates of treatment response using research blood samples collected at baseline and post-treatment.
Measured: 12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Paricalcitol [Efficacy]
Evaluation of circulating biomarkers of treatment response using research blood samples collected at baseline and post-treatment.
Measured: 12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Pirfenidone [Efficacy]
Evaluation of circulating biomarkers of treatment response using research blood samples collected at baseline and post-treatment.
Measured: 12 weeks
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in Ki-67 positive tumor cells
Measured: 12 weeks
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in Ki-67 positive tumor cells
Measured: 12 weeks
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in density of Fibroblast Activation Protein-positive (FAP+)
Measured: 12 weeks from treatment initiation
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in density of Fibroblast Activation Protein-positive (FAP+)
Measured: 12 weeks from treatment initiation
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples measuring changes in collagen density (quantified via Sirius Red or Masson's Trichrome staining).
Measured: 12 weeks from treatment initiation
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples measuring changes in collagen density (quantified via Sirius Red or Masson's Trichrome staining).
Measured: 12 weeks from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal (Metastatic) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is randomized 1:1 into two parallel intervention arms
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Wagner, MD, FACS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Wagner, MD, FACS, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Patrick Wagner, Principal investigator, AHN Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856914
- Sponsor's protocol ID
- 2026-077
- Acronym
- RANDY 1A
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of data or bio-specimens is not currently planned and will require a separate IRB application and a Material Transfer Agreement (MTA) or Data Use Agreement (DUA), as applicable, in the event that such plans arise in the future