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

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 17, 2025

Primary Completion Date

November 1, 2030

Study Completion Date

June 1, 2032

Conditions
Esophageal CancerOesophageal CancerGastroEsophageal Cancer
Interventions
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.

Trial Locations (1)

53226

RECRUITING

Froedtert & the Medical College of Wisconsin, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER