Esophageal CancerPhase 2NCT06906887
PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
A Phase 2 study testing Induction Chemotherapy (modified FLOT or modified FOLFOX-6), Chemotherapy and Conventional Radiation in people with Esophageal Cancer and Oesophageal Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Oesophageal Cancer, GastroEsophageal Cancer
- What is being tested?
- Induction Chemotherapy (modified FLOT or modified FOLFOX-6), Chemotherapy and Conventional Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2025to 1 Jun 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A potential study subject who meets all of the following inclusion criteria is eligible to participate in the study.
- Age ≥ 18 years.
- Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).
- Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+/- esophagectomy).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate hematologic function within 30 days prior to registration defined as follows:
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- Absolute Neutrophil Count ≥ 1,500/mcg
- Hemoglobin ≥ 8 gm/dL
- Platelets ≥ 100,000/mcL.
- Adequate renal function within 30 days prior to registration, defined as a creatinine clearance of ≥ 50 ml/min as calculated by the Cockcroft-Gault equation.
- Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN
- Note: patients with known Gilbert Syndrome can have a total bilirubin < 2.5 x upper limit of normal (ULN).
- Female patients <65 years of age and of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months.
- Patients of reproductive potential must agree to use effective contraception for the duration of study treatment. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method, or intrauterine device.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Age < 18 years.
- Extensive distant metastatic cancer, defined as >5 metastases.
- Recurrent esophageal cancer.
- Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e., treatment-associated toxicity).
- Prior non-approved chemotherapy for the treatment of cancer.
- Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.
- Women must not be pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Lindsay Puckett, MD, 414-805-4400, lpuckett@mcw.edu
Lindsay Puckett, MD
About this study
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.
Read the 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.
- Being tested
- Induction Chemotherapy (modified FLOT or modified FOLFOX-6), Chemotherapy, Conventional Radiation, Pulsed Low-Dose-Rate (PLDR) Radiation, Surgery
- Keywords
- Pulsed Low-Dose-Rate Radiation, Chemoradiation, esophagitis, Esophagectomy, Esophageal Cancer, Oesophageal Cancer, GastroEsophageal Cancer, Pulsed reduced dose rate radiation, Pulsed radiation
- Medical subject headings
- Esophageal Neoplasms, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction Chemotherapy (modified FLOT or modified FOLFOX-6)Drug
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.
ChemotherapyDrug
The preferred concurrent chemoradiation is carboplatin/paclitaxel weekly.
Conventional RadiationRadiation
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.
Pulsed Low-Dose-Rate (PLDR) RadiationRadiation
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.
SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Low-Dose-Rate Radiation (PLDR) | Experimental | Neoadjuvant radiation delivered in short pulses; same dose as standard chemoradiation arm. Receives: Drug: Induction Chemotherapy (modified FLOT or modified FOLFOX-6); Drug: Chemotherapy; Radiation: Pulsed Low-Dose-Rate (PLDR) Radiation; Procedure: Surgery |
| Standard Chemoradiation | Experimental | Standard (non-pulsed) neoadjuvant radiation; same dose as PLDR arm. Receives: Drug: Induction Chemotherapy (modified FLOT or modified FOLFOX-6); Drug: Chemotherapy; Radiation: Conventional Radiation; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
New prescription for narcotics
The number of subjects requiring a new prescription for narcotics.
Measured: Up to 6 weeks after radiation treatment
Increasing existing narcotics
The number of subjects increasing existing narcotics by 25%.
Measured: Up to 6 weeks after radiation treatment
Oral intake
The number of subjects transitioning from solid to liquid or liquid to no oral intake.
Measured: Up to 6 weeks after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start17 Jun 2025
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Puckett, MD, Medical College of Wisconsin
- Investigators
- Lindsay Puckett, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906887
- Sponsor's protocol ID
- PRO00049620
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No