Adaptive Radiation for Abdominopelvic Cancer

Overseen By Joshua Meyer, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fox Chase Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Peritoneal carcinomatosis, 6+ metastases, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation treatment, called adaptive stereotactic body radiation, for individuals with cancer that has spread to the abdomen or pelvis. The goal is to determine if this method can better target tumors without causing serious side effects. It is intended for patients with an active cancer spot in the abdomen or pelvis that has not received prior radiation treatment. Participants should have a cancer diagnosis and require local control or symptom relief. This could be a promising option for those seeking new treatments for metastatic cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational drugs while participating in this trial.

What prior data suggests that adaptive stereotactic body radiation is safe for abdominopelvic cancer?

Research has shown that adaptive stereotactic body radiation therapy (SBRT) is generally well-tolerated by patients with cancer that has spread to the abdomen or pelvis. Studies have found that this type of radiation treatment can limit radiation exposure to healthy tissues, potentially reducing side effects.

In another study, patients reported maintaining a good quality of life after receiving this treatment, indicating they did not experience severe side effects. Adaptive SBRT aims to keep serious side effects (grade 3 or higher) at 10% or less.

Although this clinical trial is in an early stage, with detailed safety data still being gathered, these findings suggest that the treatment is likely safe with manageable side effects for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Adaptive Stereotactic Body Radiation for abdominopelvic cancer because it offers a more personalized approach to radiation therapy. Unlike traditional radiation treatments, which follow a set schedule and dose, this method adapts to the patient's specific anatomy and tumor response, potentially increasing effectiveness and minimizing damage to surrounding healthy tissues. Additionally, this technique allows for precise targeting of tumors with high doses of radiation over a shorter period, which may lead to better outcomes and fewer side effects compared to conventional methods.

What evidence suggests that adaptive stereotactic body radiation is effective for abdominopelvic cancer?

Research has shown that adaptive stereotactic body radiation therapy (SBRT), which participants in this trial will receive, can effectively treat tumors in the abdomen and pelvis. Studies have found that it controls cancer growth in the treated area for 97% of patients at six months and 93% at one year, meaning the cancer does not grow in the treated area for most patients. Adaptive SBRT enables doctors to deliver a higher dose of radiation while minimizing serious side effects. Early reports also indicate that patients maintain a good quality of life during treatment. These findings suggest that adaptive SBRT is a promising option for managing cancer that has spread to the abdomen or pelvis. ^{1 4 6 7 8}

Who Is on the Research Team?

Joshua E. Meyer

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic cancer in the abdomen or pelvis, who have at least one lesion not treated by radiation or growing. They must have acceptable liver and kidney function, a certain level of blood cells, an ECOG performance status of 0 or 1, and be expected to live at least another year. Pregnant women, those with too many metastases (6+), prior radiotherapy on target lesions, uncontrolled illnesses, or severe toxicity from past treatments are excluded.

Inclusion Criteria

Estimated survival of >/= 12 months

I am older than 18 years.

I am fully active or can carry out light work.

Exclusion Criteria

My scans show cancer spread in my abdomen.

I have active cancer spots outside my abdomen and pelvis.

Receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Adaptive stereotactic body radiation (SBRT) treatment with dose escalation to find the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

3-4 weeks

Multiple visits for simulation and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, assessing for severe (grade 3) toxicity

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Stereotactic Body Radiation

Trial Overview The trial tests adaptive stereotactic body radiation therapy (SBRT) for patients with abdominopelvic metastases. It's a Phase I study aiming to increase the dose while keeping serious side effects under control. The goal is local tumor control or symptom relief using advanced SBRT that adapts to changes during treatment.

How Is the Trial Designed?

Group I: Adaptive Stereotactic Body Radiation Experimental Treatment 1 Intervention

Simulation and treatment to be performed over 3-4 weeks per dose escalation

Adaptive Stereotactic Body Radiation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Abdominal metastases
• Pelvic metastases

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Abdominal metastases
• Pelvic metastases

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Abdominal metastases
• Pelvic metastases

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Published Research Related to This Trial

The Phase I trial involving 20 patients demonstrated that Stereotactic, Magnetic Resonance-guided Online-Adaptive Radiotherapy (SMART) is a feasible and safe method for treating abdominal malignancies, with no severe acute treatment-related toxicities observed.

SMART allowed for real-time adaptation of treatment plans in 81 out of 97 fractions, improving target volume coverage while protecting nearby organs-at-risk, which enhances the potential effectiveness of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Henke, L., Kashani, R., Robinson, C., et al.[2022]

Stereotactic magnetic resonance-guided adaptive radiation therapy (SMART) was found to be feasible and safe for treating abdominopelvic oligometastases in 101 patients, with a high 12-month local control rate of 93%.

The treatment showed excellent overall survival rates of 96%, particularly for prostate adenocarcinoma patients, who had a 100% survival rate, indicating that SMART could be a promising standard treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Magnetic Resonance-Guided Adaptive Radiation Therapy (SMART) for Abdominopelvic Oligometastases. Yang, DD., Brennan, VS., Huynh, E., et al.[2022]

Ablative robotic stereotactic body radiosurgery (SBRT) was safely administered to 50 women with recurrent gynecologic cancers, with a 96% target response rate and a 68% clinical benefit observed at 6 months.

The treatment resulted in a median overall survival of 20.2 months, although a significant 62% of patients experienced non-radiosurgical disease relapse, indicating the need for further studies combining SBRT with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies. Kunos, CA., Brindle, J., Waggoner, S., et al.[2021]

In a study of 40 lung SBRT patients, adaptive planning significantly reduced radiation dose to organs-at-risk (OARs) compared to nonadaptive plans, indicating improved safety for surrounding tissues during treatment.

The effectiveness of adaptive planning was correlated with changes in tumor volume and distances to OARs, suggesting that larger tumor shrinkage during treatment can lead to better dosimetric outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive stereotactic body radiation therapy planning for lung cancer. Qin, Y., Zhang, F., Yoo, DS., et al.[2018]

The study demonstrated that online adaptive MR-guided stereotactic body radiation therapy (SBRT) is feasible and well-tolerated in 25 patients with unresectable upper abdominal tumors, with 84% of treatment fractions completed within 60 minutes.

No severe acute toxicity (grade 3 or higher) was reported, and the treatment successfully alleviated pain in 11 out of 13 patients, indicating both safety and efficacy in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. Daamen, LA., de Mol van Otterloo, SR., van Goor, IWJM., et al.[2022]

The study demonstrated that online adaptive stereotactic body radiotherapy (SBRT) is feasible for treating locally advanced pancreatic cancer and oligometastatic lymph nodes, with treatment times ranging from 64 to 83 minutes, which is comparable to existing clinical solutions.

Using quick treatment plan templates based on repeat CT scans resulted in effective treatment plans that adhered to organ at risk (OAR) constraints, indicating that this method can maintain treatment quality despite inter-fraction motion in the abdomen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical feasibility of online adaptive stereotactic treatments in the abdomen on a robotic radiosurgery system. Milder, MTW., Magallon-Baro, A., den Toom, W., et al.[2022]

The first reported case of cone beam CT-guided stereotactic adaptive radiotherapy (CT-STAR) for pancreatic cancer demonstrated successful treatment in a 61-year-old female patient, allowing for precise targeting while minimizing damage to critical organs.

CT-STAR effectively adhered to strict safety constraints, achieving all hard constraints for critical gastrointestinal structures across five treatment fractions, which would have been violated by the initial treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first reported case of a patient with pancreatic cancer treated with cone beam computed tomography-guided stereotactic adaptive radiotherapy (CT-STAR). Kim, M., Schiff, JP., Price, A., et al.[2023]

Stereotactic body radiation therapy (SBRT) for abdominal or pelvic tumors showed promising results, with 36% of lesions achieving a complete response and 90% overall survival at 12 months among 47 patients treated for 50 lesions.

The treatment was well-tolerated, with no severe acute toxicities reported, although there were some late toxicities, indicating that SBRT can be a safe and effective option for managing these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and dosimetric considerations using stereotactic body radiotherapy for abdominopelvic tumors. Barney, BM., Olivier, KR., Macdonald, OK., et al.[2022]

Stereotactic body radiation therapy (SBRT) demonstrated good local control in treating oligometastatic ovarian cancer, with 60% of lesions showing a complete radiologic response and a median local progression-free survival rate of 68%.

The treatment had a favorable safety profile, with no severe toxicities reported, and allowed for a median systemic treatment-free interval of 7.4 months, making it a viable option for patients unable to undergo further systemic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Oligometastatic Ovarian Cancer: A Step Toward a Drug Holiday. Lazzari, R., Ronchi, S., Gandini, S., et al.[2019]

An 86-year-old woman with early-stage endometrial carcinoma, who was medically inoperable, successfully underwent stereotactic body radiotherapy (SBRT) and achieved complete metabolic and radiological responses.

The treatment was well-tolerated with only mild side effects, and the patient remained disease-free after one year, suggesting that SBRT could be a safe and effective option for patients with inoperable early-stage endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided Stereotactic Body Radiation Therapy for Medically Inoperable Endometrial Cancer. Dincer, N., Abacioglu, UM., Tezcanli, E., et al.[2023]

Online adaptive radiotherapy using a 1.5 Tesla MR-linac is a feasible method for delivering stereotactic body radiotherapy (SBRT) to pelvic lymph node oligometastases, allowing for daily adjustments based on patient anatomy.

The treatment sessions are efficient, lasting less than 60 minutes, and quality assurance tests confirm the accuracy and reliability of the radiation delivery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of stereotactic radiotherapy using a 1.5 T MR-linac: Multi-fraction treatment of pelvic lymph node oligometastases. Werensteijn-Honingh, AM., Kroon, PS., Winkel, D., et al.[2022]

Citations

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Adaptive Stereotactic Body Radiation Therapy in the ... This case study therefore demonstrates the successful treatment of a large oligometastatic abdominopelvic tumor using CT-based A-SBRT and builds ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624037131

Results of a Single-Arm Phase 2 Clinical Trial: Online ... Publications on online adaptive treatments found an LC of 97% at 6 months and a 1-year LC of 93% for online adaptive therapy for abdominal malignancies using ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05880667

Adaptive Radiation for Abdominopelvic Metastases Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with ...

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Patient-Reported Quality-of-Life Outcomes After ... In this study, we present prospectively collected HRQoL data after abdominopelvic stereotactic body radiation therapy (SBRT) on a 1.5T MRL system.

5. 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.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-07371

Adaptive Stereotactic Body Radiation Therapy for the ... Adaptive SBRT may decrease radiation to healthy tissue and reduce side effects in patients with abdominal and pelvic metastases. Eligibility Criteria ...

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Patient-Reported Quality-of-Life Outcomes After ... Stereotactic radiation treatments using online adaptive MR guided radiation therapy on MRL are well tolerated in patients with abdominopelvic metastases.

8. redjournal.org redjournal.org/article/S0360-3016(24)03713-1/fulltext

Results of a Single-Arm Phase 2 Clinical Trial This study reports on the clinical outcomes of the single-arm phase-2 STEAL trial investigating online adaptive stereotactic body radiation therapy (SBRT) for ...