Perioperative FLOT(D) With Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Esophageal Cancer
United States15 participantsStarted 2026-10-01
Plain-language summary
The goal of this clinical trial is to learn the safety of the addition of PULSAR radiation to standard of care chemotherapy and immunotherapy in people with esophageal and gastroesophageal junction cancer and to determine the safest dose of radiation that can be used.
Participants in this study will be undergoing clinically scheduled procedures. In addition to the standard of care visits and treatments, there will be additional visits and assessments with radiation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years of age at date of enrollment. Both men and women and members of all races and ethnic groups will be included.
. Willing and able to provide written informed consent.
. Pathologic diagnosis of esophageal or gastroesophageal junction adenocarcinoma. GEJ cancer includes Siewart types 1 and 2 tumors. Siewart type 3 is also eligible as long as the patient is intended to be treated in the same way as for type 1 and 2 tumors (i.e. candidate for FLOT-(D), resectable, amenable to radiation)
. T1N+ or T2-4N(any) by the American Joint Committee on Cancer staging manual 8th edition
. Primary tumor (and lymph nodes) that appear to be resectable in the opinion of an experienced thoracic surgeon or surgical oncologist 19.
. Measurable disease by RECIST 1.1 is not a requirement in order to enroll on this study. Those who have measurable disease at baseline will be followed by RECIST 1.1 criteria at time of restaging.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended phase 2 dose (RP2D) of PULSAR
Timeframe: First administration of radiotherapy (RT) to 60 days after completion of RT or day of surgery, whichever occurs first
Trial details
NCT IDNCT07700420
SponsorUniversity of Texas Southwestern Medical Center
. Primary tumor (and applicable nodal sites) that appears amenable to radiation in the opinion of an experienced radiation oncologist.
. Eastern cooperative Oncology Group (ECOG) performance status of 0-1
Exclusion criteria
. Patients with adenosquamous cell carcinoma, squamous cell carcinoma, GI stromal tumor, or neuroendocrine tumor (any grade) of the esophagus or GEJ.
. Receipt of prior chemotherapy, radiotherapy, or both for esophageal or gastroesophageal junction cancer (any type).
. Any other active malignancies besides localized skin cancers or in situ carcinomas. Patients with localized prostate or breast cancers who have been stable for ≥ 6 months on adjuvant therapy without evidence of active disease will be eligible to enroll on this study. Patients with a history of cancer that has not been active in the last 5 years may be included but only after consultation with the principal investigator.
. Prior RT to the chest or abdomen (not esophagus/GEJ) that would, in the opinion of a radiation oncologist, limit the safety of PULSAR.
. Known dihydropyrimidine dehydrogenase (DPYD) intermediate or poor metabolizer phenotype where administration of full dose 5-fluoruracil would be prohibitively toxic. It is not a requirement to test DPYD deficiency prior to enrollment. Patients found to be DPYD intermediate or poor metabolizers through the course of standard of care evaluation will be removed from the protocol and followed for DLTs. These patients will be replaced.
. Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements or that would be prohibitive of a surgical resection in the opinion of a surgical oncologist or thoracic surgeon.
. Chemotherapy, or other systemic cancer therapy for non-esophageal or GEJ cancer within 52 weeks prior to starting study treatment (with the exception of long-term adjuvant therapy for curative-intent prostate or breast cancer, as defined above).
. History of allergic reactions attributed to compounds of similar chemical or biologic composition to FLOT chemotherapy, durvalumab or other agents used in study.