Ablative Stereotactic MR-Guided Adaptive Reirradiation

Launched by BAPTIST HEALTH SOUTH FLORIDA · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach called reirradiation for patients with abdominal or pelvic cancer who have already received radiation therapy in the past. The goal is to determine how safe this second round of radiation is and to learn about its effects, both positive and negative, on tumors in these areas. The trial is currently looking for participants aged 65 to 74, regardless of gender, who have one specific tumor in the abdomen or pelvis and who completed their last radiation treatment at least six months ago.

To be eligible, participants need to have had at least one previous course of radiation therapy that delivered a certain dose to their tumor and must meet specific health criteria, such as having a reasonable life expectancy and being able to undergo an MRI scan. Those who join the study can expect to receive close monitoring during the treatment process, and they will need to follow certain guidelines, like using contraception if they can become pregnant. Overall, this trial aims to gather important information that could help improve future cancer treatments for patients in similar situations.

Gender

ALL

Eligibility criteria

• 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