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Hypofractionated Radiation Therapy for Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Led By Sarah L Davis
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of M3814 given with radiation therapy to treat patients with localized pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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
Maximum tolerated dose (Phase I)
Progression-free survival rate (Phase II)
Recommended phase 2 dose (Phase I)
Secondary outcome measures
Disease control rate
Gene signature of tumor
Overall response rate
+3 more
Other outcome measures
Gene signature of cell-free DNA from peripheral blood

Side effects data

From 2022 Phase 2 trial • 107 Patients • NCT03324802
80%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase II Group I (hypofractionated radiation therapy M3814)Experimental Treatment6 Interventions
Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity.Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Group II: Phase I (hypofractionated radiation therapy, M3814)Experimental Treatment6 Interventions
Patients in Phase I undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity.Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Group III: Phase II Group II(hypofractionated radiation therapy, placebo)Placebo Group6 Interventions
Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Peposertib
2021
Completed Phase 1
~20
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,569 Total Patients Enrolled
Sarah L DavisPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Media Library

Hypofractionated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04172532 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Phase II Group II(hypofractionated radiation therapy, placebo), Phase I (hypofractionated radiation therapy, M3814), Phase II Group I (hypofractionated radiation therapy M3814)
Pancreatic Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04172532 — Phase 1 & 2
Hypofractionated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04172532 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to Radiation Therapy for Localized Pancreatic Cancer
2021. "Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to Radiation Therapy for Localized Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04172532.
~7 spots leftby Aug 2024
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