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

Trial Summary

What is the purpose of this trial?

Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) 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 metastatic cancer to the abdomen or pelvis requiring local control or palliation will be enrolled.

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 data supports the effectiveness of the treatment Adaptive Stereotactic Body Radiation for abdominopelvic cancer?

Research shows that adaptive stereotactic body radiation therapy (SBRT) is feasible and potentially beneficial for treating tumors in the abdomen and pelvis. Studies indicate that using advanced imaging techniques, like MR-guided systems, can improve the precision and effectiveness of SBRT by adapting to changes in the patient's anatomy during treatment. ^{1 2 3 4 5}

Is adaptive radiation therapy safe for treating abdominopelvic cancer?

Research shows that stereotactic body radiation therapy (SBRT), a form of adaptive radiation, is generally safe for treating various cancers, including abdominopelvic tumors. Studies report mild side effects like increased vaginal discharge, with no long-term side effects observed in some cases, indicating a safe toxicity profile. ^{5 6 7 8 9}

How is Adaptive Stereotactic Body Radiation Therapy (SBRT) different from other treatments for abdominopelvic cancer?

Adaptive Stereotactic Body Radiation Therapy (SBRT) is unique because it uses real-time imaging, like MRI or CT, to adjust the radiation plan daily, allowing for precise targeting of tumors while minimizing damage to nearby organs. This adaptability is particularly beneficial for treating tumors in the abdomen where organs can move, improving safety and effectiveness compared to traditional radiation therapies. ^{1 4 5 10 11}

Research Team

Joshua E. Meyer

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Ireland 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. [2022]

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

Adaptive stereotactic body radiation therapy planning for lung cancer. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

Feasibility of stereotactic radiotherapy using a 1.5 T MR-linac: Multi-fraction treatment of pelvic lymph node oligometastases. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Technical feasibility of online adaptive stereotactic treatments in the abdomen on a robotic radiosurgery system. [2022]

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

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. [2022]

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

Clinical outcomes and dosimetric considerations using stereotactic body radiotherapy for abdominopelvic tumors. [2022]

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

Stereotactic Body Radiation Therapy for Oligometastatic Ovarian Cancer: A Step Toward a Drug Holiday. [2019]

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

Magnetic Resonance Imaging-Guided Stereotactic Body Radiation Therapy for Medically Inoperable Endometrial Cancer. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies. [2021]

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

Stereotactic Magnetic Resonance-Guided Adaptive Radiation Therapy (SMART) for Abdominopelvic Oligometastases. [2022]

11. England 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). [2023]