Pulsed Low-Dose-Rate Radiation for Esophageal Cancer

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Disqualifiers: Extensive metastases, Recurrent cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new radiation treatment, Pulsed Low-Dose-Rate (PLDR) Radiation, can reduce the risk of severe esophagitis (painful inflammation of the esophagus) compared to standard radiation treatment. The trial focuses on individuals with specific stages of esophageal cancer undergoing chemoradiation treatment. Suitable candidates have stage II-IVb esophageal adenocarcinoma and are currently receiving or have received chemotherapy, with plans for further treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Pulsed Low-Dose-Rate radiation technique is safe for esophageal cancer patients?

Research has shown that pulsed low-dose-rate (PLDR) radiation is generally well-tolerated by patients. Studies have found that this method can reduce side effects while remaining effective against cancer. PLDR radiotherapy excels at targeting cancer cells and aids healthy cells in recovering faster, resulting in fewer side effects compared to standard radiation treatments.

Additionally, other studies have reported good survival rates for patients using PLDR. Although re-irradiation can sometimes increase risks like esophageal damage or lung inflammation, recent research suggests that PLDR is safer. This treatment is still under investigation, so ongoing trials are crucial to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about pulsed low-dose-rate (PLDR) radiation for esophageal cancer because it offers a new way to deliver radiation that could enhance treatment effectiveness. Unlike standard chemoradiation, which administers radiation continuously, PLDR delivers it in short bursts. This pulsed delivery method may reduce damage to healthy tissues while maintaining the same dose intensity against cancer cells. This approach could potentially improve patient outcomes by minimizing side effects and enhancing the precision of the radiation targeting cancer cells.

What evidence suggests that the Pulsed Low-Dose-Rate radiation technique is effective for esophageal cancer?

Research has shown that Pulsed Low-Dose-Rate (PLDR) radiation can effectively treat esophageal cancer. In this trial, participants will receive either PLDR radiation or standard chemoradiation. Studies have found that PLDR increases cancer cells' sensitivity to treatment, aiding in tumor attack while allowing healthy tissue to heal better. Specifically, patients who received PLDR demonstrated good survival rates, living for a median of 45 months. Additionally, PLDR is associated with fewer side effects than standard radiation, enhancing patient comfort and quality of life. Overall, PLDR shows promise in effectively treating esophageal cancer while minimizing harm to healthy tissue. ^{1 2 3 5 6}

Who Is on the Research Team?

Lindsay Puckett, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for individuals with esophageal cancer who can undergo chemotherapy and radiation, followed by surgery. Specific details on inclusion and exclusion criteria are not provided, but typically participants must be adults with confirmed diagnosis and fit enough for the treatments.

Inclusion Criteria

Adequate hematologic function within 30 days prior to registration: Absolute Neutrophil Count ≥ 1,500/mcg, Hemoglobin ≥ 8 gm/dL, Platelets ≥ 100,000/mcL

Patients of reproductive potential must agree to use effective contraception for the duration of study treatment

Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

I am under 18 years old.

My cancer has spread to more than 5 places in my body.

My esophageal cancer has come back, but other cancers I have do not affect this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Pulsed Low-Dose-Rate radiation or standard chemoradiation for esophageal cancer

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pulsed Low-Dose-Rate (PLDR) Radiation

Trial Overview The PULSO Trial compares two types of radiation therapy during chemoradiation: a new technique called Pulsed Low-Dose-Rate (PLDR) Radiation versus the standard method. It's to see if PLDR reduces severe esophagitis side effects.

How Is the Trial Designed?

Group I: Standard Chemoradiation Experimental Treatment 4 Interventions

Standard (non-pulsed) neoadjuvant radiation; same dose as PLDR arm.

Group II: Pulsed Low-Dose-Rate Radiation (PLDR) Experimental Treatment 4 Interventions

Neoadjuvant radiation delivered in short pulses; same dose as standard chemoradiation arm.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. foxchase.org foxchase.org/news/newer-radiation-technique-reduces-side-effects-while-maintaining-effectiveness

Newer Radiation Technique Reduces Side Effects While ... Strong Survival Outcomes: Patients achieved a median overall survival of 45 months. Comparable Response Rates: Among esophageal cancer patients ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03094884

NCT03094884 | Pulsed Low Dose Rate Radiation With ... The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6620741/

Safety and efficacy of pulsed low-dose rate radiotherapy for ... Studies have shown that pulsed low-dose rate radiotherapy (PLDR) induces a hypersensitivity effect on tumor tissue and a hyper-repair effect on normal tissue, ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2019/06280/safety_and_efficacy_of_pulsed_low_dose_rate.62.aspx

Safety and efficacy of pulsed low-dose rate radiotherapy... Studies have shown that pulsed low-dose rate radiotherapy (PLDR) induces a hypersensitivity effect on tumor tissue and a hyper-repair effect on normal tissue, ...

5. cco.amegroups.org cco.amegroups.org/article/view/139535/html

Pulsed reduced dose rate radiotherapy: a narrative review - Atak PRDR radiotherapy, delivered at a median dose of 54 Gy over fractions of 1.8–2.0 Gy, demonstrated promising efficacy with a 92% estimated 2-year local control ...

6. appliedradiationoncology.com appliedradiationoncology.com/articles/fox-chase-study-finds-modern-radiation-technique-improves-patient-safety-while-preserving-outcomes

Fox Chase Study Finds PLDR Improves Patient Safety ... Strong Survival Outcomes: Patients reached a median overall survival of 45 months. Comparable Response Rates: Among esophageal cancer patients ...