Hypofractionated Radiation Therapy for Pancreatic Cancer

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, NH
Pancreatic Cancer+6 More ConditionsHypofractionated Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
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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
  • Pancreatic Cancer Locally Advanced
  • Unresectable Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage IIB Pancreatic Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: At 2 years

At 2 years
Two-year OS
Baseline and after treatment
Gene signature of cell-free DNA from peripheral blood
Year 2
Overall survival (OS)
Year 2
Progression-free survival rate (Phase II)
Up to 14 days
Maximum tolerated dose (Phase I)
Recommended phase 2 dose (Phase I)
Up to 2 years
Disease control rate
Gene signature of tumor
Overall response rate
Pharmacokinetic markers of M3814

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

3 Treatment Groups

Phase I (hypofractionated radiation therapy, M3814)
1 of 3
Phase II Group I (hypofractionated radiation therapy M3814)
1 of 3
Phase II Group II(hypofractionated radiation therapy, placebo)
1 of 3

Experimental Treatment

Non-Treatment Group

98 Total Participants · 3 Treatment Groups

Primary Treatment: Hypofractionated Radiation Therapy · Has Placebo Group · Phase 1 & 2

Phase I (hypofractionated radiation therapy, M3814)Experimental Group · 6 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Peposertib, Hypofractionated Radiation Therapy · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Radiation
Phase II Group I (hypofractionated radiation therapy M3814)Experimental Group · 6 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Peposertib, Hypofractionated Radiation Therapy · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Radiation
Phase II Group II(hypofractionated radiation therapy, placebo)PlaceboComparator Group · 6 Interventions: Biopsy, Placebo Administration, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Hypofractionated Radiation Therapy · Intervention Types: Procedure, Other, Procedure, Procedure, Procedure, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~810
Computed Tomography
2017
Completed Phase 2
~2710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Nedisertib
Not yet FDA approved
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,278 Previous Clinical Trials
41,234,732 Total Patients Enrolled
Sarah L DavisPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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