28 Participants Needed

Ablative Radiation Treatment for Cancer

(STM-06 Trial)

RN
OQ
Overseen ByOmer Qazi
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Illinois at Chicago
Must be taking: Immunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation treatment, ablative radiation treatment, to determine its effectiveness for people with advanced solid tumor cancer. It focuses on patients already receiving immunotherapy who have 3 to 10 metastatic lesions. The trial divides participants into two groups: one for those whose cancer has stopped growing or shrunk after at least 3 months of immunotherapy, and another for those with some new growths but who previously responded well to immunotherapy. Individuals who have been on immunotherapy for over 3 months and have 3 to 10 cancer spots outside certain areas, such as the gut or brainstem, are suitable candidates for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you must have been on immunotherapy for at least 30 days before joining. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ablative radiation treatment is generally safe and well tolerated. Studies have found it effective and safe for patients with a small number of cancer spread areas. For example, a review of multiple studies found that patients with these conditions usually handle the treatment without major problems. Another study highlighted its safety for those with colorectal cancer, where it was effective and did not cause harmful side effects. In summary, current evidence suggests that ablative radiation treatment is safe for people with limited cancer spread.12345

Why are researchers excited about this trial's treatment?

Ablative radiation treatment is unique because it offers a more precisely targeted approach to treating cancer, especially in patients with oligo-progression and those with stable disease or partial response. Unlike standard radiation therapy, which often affects larger areas, ablative radiation focuses intense doses on small, specific sites of cancer. This targeted method aims to minimize damage to surrounding healthy tissues and potentially improve outcomes for patients who have shown some response to immunotherapy. Researchers are excited about this treatment because it could offer a more effective and less invasive option for managing cancer progression in these particular patient groups.

What evidence suggests that ablative radiation treatment could be effective for cancer?

Research has shown that a type of radiation treatment called ablative radiation can be effective for some cancers. In this trial, participants will receive ablative radiation treatment in different contexts. One study found that patients who received stereotactic ablative radiotherapy (SABR) lived 22 months longer on average than those who did not receive this treatment. Another study found that SABR helped patients go longer without their cancer worsening. SABR is also well tolerated and works well for colorectal cancer that has metastasized. These findings suggest that ablative radiation treatment may help control cancer spread and improve survival in patients with metastatic cancer.36789

Who Is on the Research Team?

RN

Ryan Nguyen, DO

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors (3-10 metastatic lesions, not in the GI tract, brainstem, or skin) who've been on FDA-approved immunotherapy for more than 3 months can join. They must have good organ function and a life expectancy of at least 3 months. Pregnant or breastfeeding women cannot participate.

Inclusion Criteria

My cancer has spread to 3-10 places, not counting the original tumor.
I am 18 years old or older.
I have been active and mostly self-sufficient in the last 30 days.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive ablative radiotherapy to up to 10 lesions

Duration not specified
Multiple visits for radiotherapy sessions

Post-treatment Monitoring

Participants undergo ctDNA collection and disease assessments, including imaging and serial ctDNA monitoring

8 weeks
1 visit for ctDNA collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including resolution of adverse events

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ablative radiation treatment

Trial Overview

The STM-06 trial tests ablative radiation treatment on patients with certain types of cancer who are already receiving immunotherapy. It's a two-arm pilot study where participants will also undergo ctDNA monitoring after treatment to assess its effectiveness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment with Radiotherapy in Patients with Oligo-progressionExperimental Treatment1 Intervention
Group II: Treatment with Radiotherapy in Participants with Stable Disease or Partial ResponseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

Effectiveness of Stereotactic Ablative Radiotherapy for ...

Stereotactic ablative radiotherapy (SABR) may improve survival in patients with inoperable pulmonary oligometastases.

Long-Term Results of the SABR-COMET Phase II ...

In this long-term report from an international randomized phase II trial, patients who received SABR demonstrated a 22-month improvement in median OS.

Outcomes of Observation vs Stereotactic Ablative ...

Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002).

Efficacy and Safety Outcomes Of Using Stereotactic ...

This study showed that stereotactic ablative radiotherapy is well tolerated and effective for colorectal oligometastases. A prescription dose of ...

Dual Benefits of Ablative Radiation in Oligometastatic ...

The UT Southwestern experience revealed a median survival of 5 months in patients who presented with polymetastatic disease. The survival curves were ...

A Systematic Review and Meta-analysis - PMC

The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.

Safety and Survival Rates Associated With Ablative ...

The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.

Feasibility and safety of single-fraction sub-ablative ...

Single-fraction sub-ablative radiotherapy combined with systemic therapy is feasible and safe in colorectal cancer patients · No clinically relevant delays in ...

Stereotactic Ablative Radiotherapy in Oligometastatic ...

Stereotactic ablative body radiotherapy (SABR) comes to the fore as a safe and effective treatment for patients with a limited number of metastases.