Reirradiation for Abdominal and Pelvic Cancer

Overseen By Carolina Rojas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baptist Health South Florida

Must not be taking: Chemotherapy, VEGF inhibitors

Disqualifiers: Pregnancy, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow concurrent hormonal therapy or immunotherapy. However, chemotherapy and VEGF inhibitors should not be given within certain timeframes around the reirradiation.

What data supports the effectiveness of the treatment Reirradiation, ReRT, Stereotactic MR-Guided Adaptive Reirradiation for abdominal and pelvic cancer?

Research shows that using MRI-guided radiotherapy for abdominal and pelvic tumors can improve precision and reduce harm to nearby tissues, making it a safer option for reirradiation. This approach has been effective in managing recurrences in various cancers, including rectal and prostate cancer, by allowing high-dose treatments with better control and fewer side effects. ^{1 2 3 4 5}

Is reirradiation for abdominal and pelvic cancer generally safe for humans?

Research suggests that using MRI-guided techniques for reirradiation in the abdomen and pelvis can improve safety by increasing precision and reducing damage to nearby tissues. This approach has shown promising results in terms of safety and feasibility for various cancers, including rectal and prostate cancer. ^{1 2 3 5 6}

How is the treatment Reirradiation (ReRT) for abdominal and pelvic cancer different from other treatments?

Reirradiation using stereotactic MR-guided adaptive radiotherapy (SMART) is unique because it uses MRI to precisely target tumors while minimizing damage to nearby healthy tissues, which is especially important in sensitive areas like the abdomen and pelvis. This approach allows for safer re-treatment of cancer that has returned after initial radiation therapy, reducing the risk of side effects compared to traditional methods. ^{1 3 4 7 8}

What is the purpose of this trial?

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.

Research Team

Michael Chuong, MD

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Eligibility Criteria

This trial is for individuals who have previously undergone radiation therapy for cancer located in the abdomen or pelvis. It aims to explore the safety of administering a second round of radiation, known as reirradiation, to these patients.

Inclusion Criteria

My previous and current radiation treatments overlap by at least 50%.

I am currently on hormonal therapy or immunotherapy.

It has been over 6 months since I finished my last radiation therapy.

Exclusion Criteria

Contraindication to having an MRI scan.

Individuals who are pregnant.

I cannot get the digital files of my previous radiation treatment plan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Reirradiation Treatment

Participants receive ablative stereotactic MR-guided adaptive reirradiation for abdominal and pelvic tumors

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of quality of life and toxicity

1 year

Treatment Details

Interventions

• Reirradiation

Trial Overview The study is testing the effects and safety of reirradiation (reRT) on tumors within the abdominal and pelvic regions that have already been treated with radiation before. The goal is to understand both positive outcomes and potential harms.

Participant Groups

Group I: Ablative Reirradiation Experimental Treatment 1 Intervention

Reirradiation is already approved in European Union, United States for the following indications:

Approved in European Union as ReRT for:

• Locally recurrent pancreatic adenocarcinoma
• Prostate cancer
• Abdominal and pelvic cancers

Approved in United States as ReRT for:

• Locally recurrent pancreatic adenocarcinoma
• Prostate cancer
• Abdominal and pelvic cancers

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Baptist Health Foundation

Collaborator

Trials

1

Recruited

10+

Findings from Research

Stereotactic MR-guided ablative radiotherapy was successfully used to treat a 39-year-old male with recurrent rectal cancer, demonstrating its potential as a safe option for patients who have already received high doses of radiation.

The use of MR-guidance in pelvic reirradiation allows for better visualization of the target area and surrounding tissues, which can enhance treatment precision and reduce toxicity to healthy organs, improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-guided Inter-fraction Monitoring Opens Doors to Delivering Safer Reirradiation: An Illustrative Case Report and Discussion. Levin-Epstein, R., Cao, M., Lee, P., et al.[2020]

Reirradiation (re-RT) for gynecological malignancies can be a potentially curative option for locoregional recurrences, and using deformable image registration (DIR) allows for more accurate cumulative dose assessments in these cases.

In a study of four patients, DIR-based dose summation showed lower cumulative doses to organs at risk compared to traditional physical summation, suggesting it may improve safety in re-RT planning, particularly for in-field nodal recurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose Accumulation for Multicourse Gynecological Reirradiation: A Methodological Narrative and Clinical Examples. Mulani, J., Jain, J., Gupta, A., et al.[2022]

Stereotactic MRI-guided adaptive radiotherapy (SMART) demonstrated a 2-year local control rate of 74% for abdominal and pelvic tumors, with significantly better outcomes for lesions treated with higher doses (BED10 ≥100).

The treatment was associated with minimal morbidity, with only 0.9% of patients experiencing acute grade three toxicities and no grade four toxicities, indicating that SMART may reduce the risk of gastrointestinal side effects compared to traditional SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of stereotactic magnetic resonance image-guided adaptive radiotherapy for primary and metastatic tumors in the abdomen and pelvis. Yoon, SM., Luterstein, E., Chu, FI., et al.[2022]

Stereotactic magnetic resonance-guided online adaptive radiotherapy (SMART) significantly improved dosimetry outcomes, with increased target volume coverage (from 89% to 95%) and reduced overdoses to organs-at-risk (from 19% to 1%) in a study of 26 patients with oligometastases.

After a median follow-up of 9.8 months, SMART demonstrated a high local control rate of 97% and a progression-free survival rate of 63%, with no severe treatment-related toxicities reported, indicating its safety and efficacy in managing complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMART ablation of lymphatic oligometastases in the pelvis and abdomen: Clinical and dosimetry outcomes. Regnery, S., Buchele, C., Piskorski, L., et al.[2022]

A multicentric retrospective analysis of 18 patients with local recurrences of prostate cancer showed that reirradiation using Magnetic Resonance guided Stereotactic Body Radiation Therapy (MRgSBRT) is feasible and can deliver high doses (25 to 40 Gy) safely, with no severe acute genitourinary toxicity reported.

The treatment resulted in a complete response in 22.2% of patients, and while some gastrointestinal toxicity was observed, the overall low rates of acute toxicity suggest that MRgSBRT is a promising option for treating relapsed prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance guided SBRT reirradiation in locally recurrent prostate cancer: a multicentric retrospective analysis. Boldrini, L., Romano, A., Chiloiro, G., et al.[2023]

In a study of 18 patients undergoing stereotactic magnetic resonance-guided online adaptive radiotherapy (SMART) for lung or liver tumors, it was found that doses to organs-at-risk (OAR) can significantly increase during adaptive treatment, necessitating careful planning for re-irradiation.

The study revealed that using cumulative dose volume histograms (DVH sum plan) and deformable image registration (DIR sum plan) for dose accumulation showed that adaptive treatment maintained similar tumor coverage compared to baseline plans, but with increased risk of OAR overdoses, highlighting the importance of using adapted plans for future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different dose accumulation strategies to estimate organ doses after stereotactic magnetic resonance-guided adaptive radiotherapy. Regnery, S., Leiner, L., Buchele, C., et al.[2023]

The first use of stereotactic MR-guided online adaptive radiation therapy (SMART reRT) for reirradiation of locally recurrent pancreatic adenocarcinoma showed promising results, allowing for dose escalation while minimizing damage to nearby gastrointestinal organs.

A 68-year-old patient tolerated the SMART reRT treatment well, receiving 50 Gy in 5 fractions with minimal fatigue, suggesting that this method may enhance the safety and efficacy of reirradiation in sensitive areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic MR-guided online adaptive radiotherapy reirradiation (SMART reRT) for locally recurrent pancreatic adenocarcinoma: A case report. Doty, DG., Chuong, MD., Gomez, AG., et al.[2021]

In a study involving 19 prostate cancer patients, the Adaptive radiation therapy plan provided better target coverage compared to the Soft plan, although the difference was not statistically significant for all parameters.

While the Adaptive plan maintained consistent dose delivery to the target volume throughout treatment, it did not improve organ-at-risk (OAR) sparing compared to the Soft plan, indicating that patient repositioning may be sufficient for maintaining treatment efficacy without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study comparing MR-guided radiation therapy (MRgRT) setup strategies for prostate treatment: repositioning vs. replanning. Kim, JI., Park, JM., Choi, CH., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-guided Inter-fraction Monitoring Opens Doors to Delivering Safer Reirradiation: An Illustrative Case Report and Discussion. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Dose Accumulation for Multicourse Gynecological Reirradiation: A Methodological Narrative and Clinical Examples. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes of stereotactic magnetic resonance image-guided adaptive radiotherapy for primary and metastatic tumors in the abdomen and pelvis. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

SMART ablation of lymphatic oligometastases in the pelvis and abdomen: Clinical and dosimetry outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance guided SBRT reirradiation in locally recurrent prostate cancer: a multicentric retrospective analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of different dose accumulation strategies to estimate organ doses after stereotactic magnetic resonance-guided adaptive radiotherapy. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Stereotactic MR-guided online adaptive radiotherapy reirradiation (SMART reRT) for locally recurrent pancreatic adenocarcinoma: A case report. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Retrospective study comparing MR-guided radiation therapy (MRgRT) setup strategies for prostate treatment: repositioning vs. replanning. [2020]