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

Trial Summary

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 data supports the effectiveness of the treatment Pulsed Low-Dose-Rate Radiation for esophageal cancer?

Research shows that Pulsed Low-Dose-Rate Radiation (PLDR) can make tumor cells more sensitive to treatment while protecting normal tissues, which has led to favorable outcomes in early studies for various cancers, including esophageal cancer. PLDR has been shown to reduce damage to normal tissues and improve control of recurrent cancers, suggesting it could be effective for esophageal cancer as well. ^{1 2 3 4 5}

Is pulsed low-dose-rate radiation generally safe for humans?

Pulsed low-dose-rate radiation (PLDR) has been shown to reduce damage to normal tissues while effectively treating tumors in various cancers, including lung, pancreatic, and prostate cancers. Early studies suggest it may also reduce serious side effects like esophageal perforation in esophageal cancer, indicating a favorable safety profile. ^{1 2 5 6 7}

How is Pulsed Low-Dose-Rate Radiation treatment different from other treatments for esophageal cancer?

Pulsed Low-Dose-Rate Radiation treatment is unique because it delivers radiation in small, spaced-out pulses, which can reduce damage to healthy tissues while effectively targeting cancer cells. This approach contrasts with conventional radiation therapies that deliver higher doses continuously, potentially leading to more side effects. ^{1 2 4 8 9}

What is the purpose of this trial?

This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.

Research Team

Lindsay Puckett, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Pulsed low dose-rate radiotherapy: radiobiology and dosimetry. [2022]

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

SU-E-T-383: Pulsed Low Dose Rate Radiotherapy Using Advanced Treatment Methods: A Novel Technique for Patient Re-Irradiation. [2019]

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

Pelvic Reirradiation Utilizing Pulsed Low-dose Rate Radiation Therapy. [2021]

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

Feasibility and tolerance of pulsed dose rate interstitial brachytherapy. [2019]

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

Safety and efficacy of pulsed low-dose rate radiotherapy for local recurrent esophageal squamous cell carcinoma after radiotherapy: Study protocol for a prospective multi-center phase II trial. [2022]

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

Local Tumor Control and Normal Tissue Toxicity of Pulsed Low-Dose Rate Radiotherapy for Recurrent Lung Cancer: An In Vivo Animal Study. [2022]

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

Intensity-modulated radiation therapy for pancreatic and prostate cancer using pulsed low-dose rate delivery techniques. [2018]

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

Pulsed brachytherapy as a substitute for continuous low dose rate: an in vitro study with human carcinoma cells. [2019]

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

Optimization strategies for pulsed low-dose-rate IMRT of recurrent lung and head and neck cancers. [2021]