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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects, both positive and negative, of administering another round of radiation therapy, known as reirradiation, to individuals with cancer in the abdomen or pelvis. The goal is to evaluate how this treatment works for tumors previously treated with radiation. Suitable candidates for this trial have a cancerous area in their abdomen or pelvis that received radiation treatment at least six months prior. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future cancer treatments.

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 prior data suggests that reirradiation is safe for abdominal and pelvic cancer?

Research has shown that reirradiation, particularly with MRI (magnetic resonance imaging), holds promise for treating tumors in the abdomen and pelvis. In one study, 74% of patients had their cancer controlled for two years, meaning the cancer did not grow in most of them during that time. This method, known as MR-guided stereotactic body radiation therapy (MRgSBRT), uses detailed imaging to target tumors precisely.

Importantly, reports indicate that this treatment is generally well-tolerated, with most patients experiencing only mild side effects. Researchers emphasize the importance of adjusting the treatment daily to protect nearby healthy tissues.

These findings suggest that while reirradiation carries risks, many patients have managed them well. This could reassure those considering joining a trial to explore this treatment further. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Reirradiation is unique because it offers a chance to treat abdominal and pelvic cancers that have previously been irradiated, pushing beyond what standard radiation therapy can achieve. Normally, once an area has been treated with radiation, additional rounds aren't an option due to the risk of damaging healthy tissue. However, with reirradiation, researchers are exploring advanced techniques that may allow for precise targeting of tumors while minimizing harm to surrounding areas. This could potentially open new doors for patients with recurrent cancers, providing another chance at effective treatment when other options have been exhausted.

What evidence suggests that reirradiation might be an effective treatment for abdominal and pelvic cancer?

Research has shown that using radiation treatment again, especially with MRI scans, can effectively treat tumors in the abdominal and pelvic areas. This trial will evaluate the effectiveness of ablative reirradiation, where MRI guidance during treatment allows doctors to adjust the radiation plan daily, protecting healthy tissues and improving safety. Studies have found that this method helps control the tumor, stopping it from growing or spreading in the treated area. Patients in these studies handled the treatment well, experiencing manageable side effects. This makes reirradiation a promising option for those whose cancer has returned after previous radiation therapy. ^{1 3 4 5 6}

Who Is on the Research Team?

Michael Chuong, MD

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8419771/

Clinical outcomes of stereotactic magnetic resonance image ...

We report the clinical outcomes of stereotactic MRI‐guided adaptive radiotherapy (SMART) for primary and metastatic tumors in the abdomen and pelvis.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301625002792

Magnetic Resonance-Guided Stereotactic Body Radiation ...

MRgSBRT reirradiation in the abdomen was well-tolerated and effective at achieving local control. Daily adaptation was critical to meet safety constraints and ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/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.

4.

redjournal.org

redjournal.org/article/S0360-3016(25)00279-2/abstract

Magnetic Resonance-Guided Stereotactic Body Radiation ...

MRgSBRT allows for dose escalation and good local control in cases of abdominal reirradiation with acceptable toxicity. Daily adaptation provided substantial ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8802055/

Dose-Escalated Magnetic Resonance Image–Guided ...

MR image guidance offers significant advantages for radiation therapy (RT) that may be particularly beneficial for reirradiation (reRT).

6.

withpower.com

withpower.com/trial/reirradiation-for-abdominal-and-pelvic-cancer-bb2f4

Reirradiation for Abdominal and Pelvic Cancer

Stereotactic MRI-guided adaptive radiotherapy (SMART) demonstrated a 2-year local control rate of 74% for abdominal and pelvic tumors, with ...