← Back to Search

Radiation Therapy for Pancreatic Cancer

Phase 1 & 2

Recruiting

Led By Erin Gillepsie, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on imaging

Has high risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risks metastases are defined as: 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterior element involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether adding radiation therapy to the standard treatment for locally advanced pancreatic cancer improves survival.

Who is the study for?

This trial is for adults with solid tumor cancers and high risk bone metastases that aren't causing significant pain. Participants should be relatively active (ECOG 0-2), have no serious health issues preventing radiation therapy, not pregnant or breastfeeding, and willing to use contraception.Check my eligibility

What is being tested?

The study is examining the effectiveness of preventative radiation therapy followed by standard treatment compared to standard treatment alone in patients with certain high-risk bone metastases from solid tumors.See study design

What are the potential side effects?

Radiation therapy may cause skin irritation at the treatment site, fatigue, mild swelling, and temporary worsening of pain before improvement ('pain flare'). Systemic therapies' side effects vary based on the specific drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has spread to more than 5 places in my body.

Select...

My bone cancer is high risk but doesn't hurt much.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

number of patients who have skeletal related events (SREs)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Selective radiation to ≤5 highest risk bone metastasesExperimental Treatment1 Intervention

Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) &/or disease with posterior element involvement.

Group II: Standard of careActive Control1 Intervention

Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,777 Total Patients Enrolled

Erin Gillepsie, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Divya Yerramilli, MD, MBEPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Palliative Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03523351 — Phase 1 & 2

Solid Tumors Research Study Groups: Selective radiation to ≤5 highest risk bone metastases, Standard of care

Solid Tumors Clinical Trial 2023: Palliative Radiation Therapy Highlights & Side Effects. Trial Name: NCT03523351 — Phase 1 & 2

Palliative Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03523351 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of this research project?

"To successfully launch this clinical trial, 78 eligible candidates must be recruited. Potential participants can visit either Memoral Sloan Kettering Westchester in Harrison, New york or Memorial Sloan Kettering Nassau in Uniondale, New jersey to take part."

Answered by AI

How many locations across the state are conducting this research?

"Present enrolment is taking place at 9 clinics, including those based in Harrison, Uniondale and Middletown. It is beneficial to select the nearest centre to reduce travel needs if you opt into this trial."

Answered by AI

Is this research project actively recruiting participants?

"According to the clinicaltrials.gov website, this medical trial is currently accepting applicants. It was initially posted on May 1st 2018 and recently updated on April 25th 2022."

Answered by AI

Recent research and studies

BMC CancerJournal

Early Palliative Radiation Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases: Study Protocol for a Randomized Controlled Trial

Rosen, Daniel B., Cory D. Benjamin, Joanna C. Yang, Connor Doyle, Zhigang Zhang, Chris A. Barker, Max Vaynrub, T. Jonathan Yang, and Erin F. Gillespie. 2020. “Early Palliative Radiation Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases: Study Protocol for a Randomized Controlled Trial”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-020-07591-w.

clinicaltrials.govStudy

Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain

2018. "Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03523351.