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Active, Not Recruiting

NCT Number: NCT06397573

Ablative Stereotactic MR-Guided Adaptive Reirradiation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Reirradiation

Radiation

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.

Primary outcomes

  1. Grade 3 or higher acute toxicity

    Time frame: 1 year

    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.

  2. Grade 5 toxicity

    Time frame: 1 year

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

Secondary outcomes

  1. Freedom from local progression (FFLP)

    Time frame: 1 year

    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).

  2. Overall survival (OS)

    Time frame: 1 year

    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.

  3. Grade 3 or higher late toxicity

    Time frame: 1 year

    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.

  4. Quality of life (QOL)

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 3, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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