NCT06906887

PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PLDR radiation technique has been shown to kill cancer cells while limiting normal tissue toxicity. In PLDR, subjects receive the same total dose of radiation for each treatment, but the treatment is delivered in a series of low-dose pulses which are separated by timed pauses. Radiation given with this approach may be less toxic but appears to be equally effective. This trial will evaluate the PLDR technique in combination with standard chemotherapy as part of definitive or curative treatment for locally advanced esophageal cancer.

Conditions

• Esophageal Cancer
• Oesophageal Cancer
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	Induction Chemotherapy (modified FLOT or modified FOLFOX-6)	Subjects are expected to receive 2-4 months of induction chemotherapy; the interval and dosages will be determined and can be modified at the discretion of their medical oncologist. The preferred induction chemotherapies are modified FLOT or FOLFOX-6. Subjects can enroll if they receive less than 2 months of induction chemotherapy as long as they are deemed to be a candidate for concurrent chemoradiation therapy.
DRUG	Chemotherapy	The preferred concurrent chemoradiation is carboplatin/paclitaxel weekly.
RADIATION	Conventional Radiation	For both standard conventional radiation therapy and PLDR radiation therapy, the standard dose (5000cGy/25fx default, 4140-5040 in 23-28 fractions) should be given. Fractions should consist of 180-200 cGy per treatment.
RADIATION	Pulsed Low-Dose-Rate (PLDR) Radiation	For both standard conventional radiation therapy and PLDR radiation therapy, the standard dose (5000cGy/25fx default, 4140-5040 in 23-28 fractions) should be given. Fractions should consist of 180-200 cGy per treatment. For PLDR radiation therapy, each fraction will be delivered as a series of 20 cGy (or 0.2 Gy) pulses that are separated by 3-minute time intervals.
PROCEDURE	Surgery	Esophagectomy is not required for trial and will be administered per medical judgement of the treating physicians. Surgery will take place at the time directed by the surgeon. This typically will take place approximately 6-13 weeks after chemoradiation therapy.

Timeline

• Start date: 2025-06-17
• Primary completion: 2030-11-01
• Completion: 2032-06-01
• First posted: 2025-04-02
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study