AzTrials
AzTrials

Abdominal CancerNCT06397573

Ablative Stereotactic MR-Guided Adaptive Reirradiation

A study testing Reirradiation in people with Abdominal Cancer and Pelvic Cancer, run by Baptist Health South Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This research study will enroll people who have cancer in their abdomen or pelvis that was treated previously with radiation therapy. The purpose of this research study is to test the safety and possible harms of treating tumors in these regions with another round of radiation therapy, called reirradiation or "reRT."… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Abdominal Cancer, Pelvic Cancer
What is being tested?
Reirradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
5 Jun 2024to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A primary or metastatic lesion in the abdomen or pelvis for which reirradiation will be delivered. There is no maximum lesion size.
  • Single course of prior radiation therapy with prescribed equivalent dose in 2 Gy fractions (EDQ210) of at least 40 Gy.
  • 50% isodose line of the prior radiation therapy course is expected to overlap at minimum the 50% isodose line of the radiation therapy delivered in this study.
  • At least 6 months from completion of prior radiation therapy to initiation of study therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Life expectancy at least 6 months.
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it is the participant's preferred method. Should a participant become pregnant or suspect pregnancy while participating in this study, the treating physician must be informed immediately.
  • Concurrent hormonal therapy or immunotherapy such as immune checkpoint inhibitor is allowed

Who cannot join

  • Contraindication to having an MRI scan.
  • Lesion that would receive study therapy arises from or invades a gastrointestinal (GI) luminal organ (a lesion abutting but not invading a GI luminal organ is permitted)
  • Lesion that would receive study therapy is not located in the abdomen or pelvis.
  • > 1 course of overlapping radiation therapy delivered to the abdomen or pelvis.
  • < 70% of the gross tumor volume (GTV) receives at least the 95% of the prescribed dose on the original plan using the simulation day anatomy.
  • More than 1 lesion in the abdomen or pelvis that requires reirradiation.
Show all 13Show fewer
  • History of inflammatory bowel disease.
  • Unable to acquire DICOM radiation therapy treatment plan from the prior radiation therapy.
  • Unresolved grade 2+ toxicity (Common Terminology Criteria for Adverse Events version 5.0) from previous anti-cancer therapy.
  • Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of participant safety or study results.
  • Individuals who are pregnant.
  • Chemotherapy given within 1 week prior to or following reirradiation.
  • Vascular endothelial growth factor (VEGF) inhibitor given within 8 weeks prior to or following reirradiation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Miami Cancer Institute at Baptist Health South Florida

    Miami, Florida, 33176

Other trials in United States

About this study

Official title: Phase 1 Trial of Ablative Stereotactic MR-Guided Adaptive Reirradiation for Abdominal and Pelvic Tumors

This research study will enroll people who have cancer in their abdomen or pelvis that was treated previously with radiation therapy. The purpose of this research study is to test the safety and possible harms of treating tumors in these regions with another round of radiation therapy, called reirradiation or "reRT." The researchers want to find out what effects (good and bad) reRT has in people with cancer in the abdomen and pelvis.

Being tested
Reirradiation
Medical subject headings
Pelvic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReirradiationRadiation

    Ablative reirradiation of 50 Gy in 5 fractions (5 sessions) that will occur once per day, either for 5 days in a row, or every other day.

Study groups in NCT06397573
Study groupRoleWhat they receive
Ablative ReirradiationExperimentalNot described
Receives: Radiation: Reirradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grade 3 or higher acute toxicity

    Number of participants who experience Grade 3 or higher acute toxicity [graded per Common Terminology Criteria for Adverse Events (CTCAE)] possibly, probably, or definitely related to reRT.

    Measured: 1 year

  2. Grade 5 toxicity

    Number of participants who experience Grade 5 toxicity (graded per CTCAE) possibly, probably, or definitely related to reRT.

    Measured: 1 year

Secondary outcomes (4)

  1. Freedom from local progression (FFLP)

    FFLP is defined as the duration of time from baseline to progressive disease (PD) in the re-irradiated lesion or death of any cause, whichever occurs first. Response to treatment will be assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: 1 year

  2. Overall survival (OS)

    OS is defined as the defined as the duration of time from baseline to death of any cause, or date of last follow-up, whichever occurs first.

    Measured: 1 year

  3. Grade 3 or higher late toxicity

    Number of participants who experience Grade 3 or higher acute toxicity [graded per Common Terminology Criteria for Adverse Events (CTCAE)] possibly, probably, or definitely related to reRT that occurs at least 90 days after reRT therapy has ended.

    Measured: 1 year

  4. Quality of life (QOL)

    QOL will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire measuring physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much), with a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher scores indicate better QOL.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start5 Jun 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06397573
Sponsor's protocol ID
2023-CHU-001
Status last verified
Feb 2026
First submitted
30 Apr 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hunt A, Das P, Minsky BD, Koay EJ, Krishnan S, Herman JM, Taniguchi C, Koong A, Smith GL, Holliday EB. Hyperfractionated abdominal reirradiation for gastrointestinal malignancies. Radiat Oncol. 2018 Aug 7;13(1):143. doi: 10.1186/s13014-018-1084-0.

    PubMed 30086784

  • Tao R, Tsai CJ, Jensen G, Eng C, Kopetz S, Overman MJ, Skibber JM, Rodriguez-Bigas M, Chang GJ, You YN, Bednarski BK, Minsky BD, Delclos ME, Koay E, Krishnan S, Crane CH, Das P. Hyperfractionated accelerated reirradiation for rectal cancer: An analysis of outcomes and toxicity. Radiother Oncol. 2017 Jan;122(1):146-151. doi: 10.1016/j.radonc.2016.12.015. Epub 2017 Jan 3.

    PubMed 28057329

  • Moningi S, Ludmir EB, Polamraju P, Williamson T, Melkun MM, Herman JD, Krishnan S, Koay EJ, Koong AC, Minsky BD, Smith GL, Taniguchi C, Das P, Holliday EB. Definitive hyperfractionated, accelerated proton reirradiation for patients with pelvic malignancies. Clin Transl Radiat Oncol. 2019 Aug 27;19:59-65. doi: 10.1016/j.ctro.2019.08.004. eCollection 2019 Nov.

    PubMed 31517071

  • Sadozye AH. Re-irradiation in Gynaecological Malignancies: A Review. Clin Oncol (R Coll Radiol). 2018 Feb;30(2):110-115. doi: 10.1016/j.clon.2017.11.013. Epub 2017 Dec 9.

    PubMed 29233573

  • Munoz F, Fiorica F, Caravatta L, Rosa C, Ferella L, Boldrini L, Fionda B, Alitto AR, Nardangeli A, Dionisi F, Arcangeli S, Di Marzo A, Pontoriero A, Donato V, Massaccesi M. Outcomes and toxicities of re-irradiation for prostate cancer: A systematic review on behalf of the Re-Irradiation Working Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO). Cancer Treat Rev. 2021 Apr;95:102176. doi: 10.1016/j.ctrv.2021.102176. Epub 2021 Mar 8.

    PubMed 33743409

  • Barsky AR, Reddy VK, Plastaras JP, Ben-Josef E, Metz JM, Wojcieszynski AP. Proton beam re-irradiation for gastrointestinal malignancies: a systematic review. J Gastrointest Oncol. 2020 Feb;11(1):187-202. doi: 10.21037/jgo.2019.09.03.

    PubMed 32175122

  • Abusaris H, Hoogeman M, Nuyttens JJ. Re-irradiation: outcome, cumulative dose and toxicity in patients retreated with stereotactic radiotherapy in the abdominal or pelvic region. Technol Cancer Res Treat. 2012 Dec;11(6):591-7. doi: 10.7785/tcrt.2012.500261. Epub 2012 May 7.

    PubMed 22568625

Questions about this trial

What is this clinical trial studying?

A study testing Reirradiation in people with Abdominal Cancer and Pelvic Cancer, run by Baptist Health South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade 3 or higher acute toxicity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06397573, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in