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Radiation Therapy

Advanced Radiation Techniques for Stem Cell Transplant Recipients

Phase 1

Waitlist Available

Led By Savita V Dandapani

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post transplant

Awards & highlights

Study Summary

This trial is testing how well two different radiation therapy techniques work to reduce doses to the lung compared to the standard method. The hope is that this will improve survival and decrease long term lung side effects in patients undergoing stem cell transplant.

Who is the study for?

This trial is for patients with acute leukemia or myelodysplastic syndrome who are suitable for stem cell transplant and total body irradiation (TBI). They must have a performance status indicating they can care for themselves, agree to use contraception, and not be pregnant. Prior treatments are allowed if completed two weeks before TBI.Check my eligibility

What is being tested?

The study tests whether advanced radiation techniques like VMAT or tomotherapy can better protect the lungs from damage during TBI compared to standard methods in patients undergoing donor stem cell transplants. The goal is to improve survival rates and reduce long-term lung complications.See study design

What are the potential side effects?

While specific side effects aren't listed, potential risks include those commonly associated with radiation therapy such as skin irritation, fatigue, nausea, and increased risk of infection due to lowered immune response post-transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post transplant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)

Secondary outcome measures

Dose homogeneity for all target and non-target structures

Extramedullary recurrence

Non-relapse mortality

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (TBI, IMRT)Experimental Treatment5 Interventions

Patients undergo TBI using IMRT with VMAT or tomotherapy BID on days -7 to -4 then undergo stem cell transplantation on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Volume Modulated Arc Therapy

2017

Completed Early Phase 1

~30

Total-Body Irradiation

1997

Completed Phase 3

~1180

Tomotherapy

2013

Completed Phase 2

~140

Hematopoietic Cell Transplantation

2006

Completed Phase 2

~360

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,647 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,440 Total Patients Enrolled

Savita V DandapaniPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

23 Total Patients Enrolled

Media Library

Tomotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04281199 — Phase 1

Myelodysplastic Syndrome Research Study Groups: Treatment (TBI, IMRT)

Myelodysplastic Syndrome Clinical Trial 2023: Tomotherapy Highlights & Side Effects. Trial Name: NCT04281199 — Phase 1

Tomotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04281199 — Phase 1

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 enrollment cap for this trial?

"Affirmative. According to the information on clinicaltrials.gov, this experiment is actively recruiting participants as of now. Initially appearing online February 28th 2020 and last updated October 7th 2022, its primary objective is to enlist 20 volunteers from a single medical facility."

Answered by AI

For whom is eligibility to participate in this experiment available?

"This trial is enrolling 20 patients between the ages of 12 and 60 with a diagnosis of leukemia. Moreover, to be selected for this study they must also comply with additional criteria including using an adequate form contraception during the course of their treatment and having satisfactory organ function determined by their hematologist. Furthermore, women of child-bearing potential must remain aware that radiation has unknown effects on developing fetuses; thus if pregnancy occurs it should be reported promptly to her physician. Finally all participants need have had recent imaging scans and laboratory tests conducted within two months prior to enrolment as well as a Karnofsky performance status score greater than or equal 70"

Answered by AI

Has the enrollment of participants in this clinical trial been opened yet?

"Affirmative, information hosts on clinicaltrials.gov verifies that this medical research is currently recruiting participants. It was initially posted in late February 2020 and the latest update occurred in early October 2022. The trial team seeks 20 patients from a single location."

Answered by AI

Are the therapeutic processes TBI and IMRT endorsed by the FDA?

"Given limited clinical data on safety and efficacy, Treatment (TBI, IMRT) received a score of 1 when assessed by the Power team."

Answered by AI

Is this trial available to participants aged 65 and over?

"The minimum age requirement to be included in this trial is 12 and the maximum age limit is 60. Additionally, there are 108 trials for minors under 18 years old and 405 clinical studies available for seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT

2020. "TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04281199.

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