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Stereotactic Body Radiation Therapy for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NCCancer+1 MoreStereotactic Body Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer treatment, Pembrolizumab, in combination with radiosurgery for people with high-grade epidural disease of the spine.

Eligible Conditions
  • Cancer
  • Epidural Spinal Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Every 2 months, up to 20 months

Month 6
Fracture
6 months
Number of Participants Completing Stereotactic Body Radiation Therapy and One Cycle of Pembrolizumab
Month 20
Number of Participants Experiencing Improvement in Pain - Numeric Pain Rating Scale (NPRS)
Month 6
Plasma Exchange
Month 6
Quality of Life - European Organization for Research and Treatment of Cancer QoL Group Bone Metastases Module (QLQ-BM22)
Month 20
Accrual Rate
Month 6
Change Thecal Sac Patency - (Percentage)

Trial Safety

Safety Progress

1 of 3

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Side Effects for

Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
55%Leukopenia
36%Thrombocytopenia
36%Lymphopenia
18%AST elevation
18%ALT elevation
18%Anemia
18%Reduced ANC
9%Sinusitis
9%Pneumonia
9%Pancreatitis
9%Hyperkalemia
9%Urinary tract infection
9%Sepsis
9%Pleural effusion
9%Acidosis
9%Cardiac disorders
9%Orthostasis
9%Rash
9%Nausea
9%Vomiting
9%Dehydration
9%Depression
9%Somnolence
9%Hypokalemia
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01959672) in the Treatment (Chemotherapy, Oregovomab, SBRT, Surgery) ARM group. Side effects include: Leukopenia with 55%, Thrombocytopenia with 36%, Lymphopenia with 36%, AST elevation with 18%, ALT elevation with 18%.

Trial Design

1 Treatment Group

Stereotactic Body Radiotherapy and Pembrolizumab Treatment
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Stereotactic Body Radiation Therapy · No Placebo Group · Phase < 1

Stereotactic Body Radiotherapy and Pembrolizumab TreatmentExperimental Group · 3 Interventions: Pembrolizumab, Blood draws, Stereotactic Body Radiation Therapy · Intervention Types: Drug, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2200
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~650

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 2 months, up to 20 months

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,146 Previous Clinical Trials
1,140,513 Total Patients Enrolled
Christina K Cramer, MDPrincipal InvestigatorWake Forest Baptist Health Sciences
1 Previous Clinical Trials
244 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate in the trial if your cancer has spread to other parts of your body, either at the same time or at different times.
You are currently taking pembrolizumab or you will be taking it within six weeks after finishing a type of radiation treatment called stereotactic body radiation therapy.
You are allowed to participate even if you have received immunotherapy treatment before.
References

Frequently Asked Questions

What is the participant count for this research project?

"Affirmative. According to information published on clinicaltrials.gov, this medical trial is still seeking applicants and was first posted online on March 28th 2022. The study requires 10 participants from a single testing centre as of May 11th 2022." - Anonymous Online Contributor

Unverified Answer

Is there currently an opportunity for people to join the research project?

"The trial is still open to patients, as noted on clinicaltrials.gov. This research was initially posted on March 28th 2022 and last revised on May 11th of the same year." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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