Gastro-esophageal Junction (GEJ) CancerPhase 1NCT07700420
Perioperative FLOT(D) With Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Esophageal Cancer
A Phase 1 study testing PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy and FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D) in people with Gastro-esophageal Junction (GEJ) Cancer and Esophagus Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-esophageal Junction (GEJ) Cancer, Esophagus Cancer
- What is being tested?
- PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy and FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to 1 Oct 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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.
Show all 16Show fewer
- 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
- No prior systemic treatment or radiation for esophageal/GEJ adenocarcinoma. Patients who have received prior endoscopic therapies with subsequent recurrence necessitating curative-intent surgery will be eligible for enrollment.
- Adequate organ and marrow function as defined below:
- 10.0 ANC ≥1500/mL 10.1 Platelet ≥100,000/mL 10.2 Total Bilirubin ≤ 1.0 x the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
- 10.3 AST and/or ALT both ≤ 1.5x ULN with alkaline phosphatase ≤2.5x ULN 10.4 Creatinine Clearance ≥ 30 mL/min by Cockroft Gault
- All men, as well as women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of radiation through 120 days after completion of adjuvant chemotherapy or immunotherapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 11a. A woman of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Unwilling or unable to undergo placement of chest wall mediport for chemotherapy administration.
- Any autoimmune condition requiring immunosuppression beyond physiologic doses of steroids will not be eligible for receipt of durvalumab. Patient would still be eligible for enrollment for receipt of perioperative FLOT only and can enroll on this study while receiving FLOT.
- Requirement of prednisone 10 mg (or prednisone equivalent) or more daily for any reason (Inhalational steroids for chronic obstructive pulmonary disease, asthma, or the like, is allowable). Patient would still be eligible for enrollment for receipt of perioperative FLOT only if they are meeting all other eligibility criteria.
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Jennifer Knight, 214-648-7097, Jennifer.Knight@UTSouthwestern.edu
About this study
Official title: A Phase I Trial of Perioperative FLOT(D) With Neoadjuvant Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Resectable Esophageal and Gastro-esophageal Junction Cancer
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.
Read the detailed description
Participants with resectable locally advanced esophageal or gastro-esophageal junction cancer will enroll to receive perioperative FLOT or FLOT(D) (standard of care) and will receive interdigitated neoadjuvant PULSAR delivered at one of three possible dose levels in four total fractions. Following completion of neoadjuvant portion of the study, patients will undergo re-evaluation for resectability and proceed to resection if it remains feasible. Following resection, patients will complete all planned curative intent therapy with four adjuvant cycles of FLOT or FLOT(D). Those who receive FLOT(D) will subsequently receive 10 cycles of adjuvant durvalumab monotherapy per standard of care1. All patients will enter follow-up on completion of FLOT chemotherapy.
- Being tested
- PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy, FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)
- Medical subject headings
- Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PULSAR- Personalized Ultra-fractionated Stereotactic Ablative RadiotherapyRadiation
-1 5.5 Gy x 4 Fractions
- 6 Gy x 4 Fractions
- 6 Gy x 4 Fractions with simultaneous boost to gross disease to 7 Gy x 4 Fractions
- 6 Gy x 4 Fractions with simultaneous boost to gross disease to 8 Gy x 4 Fractions
FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)Drug
5-fluorouracil 2600 mg/m2 leucovorin 200 mg/m2 ad oxaliplatin 85 mg/m2 docetaxel 50 mg/m2 Durvalumab 1500 mg All medications are administered intravenously via mediport.
| Study group | Role | What they receive |
|---|---|---|
| PULSAR radiation in combination with perioperative FLOT(D) | Experimental | PULSAR radiation plus FLOT(D)
Each cycle of FLOT(D) consists of 5-fluorouracil 2600 mg/m2 administered over 24 hours, leucovorin 200 mg/m2 administered over 2 hours, oxaliplatin 85 mg/m2 administered over 2 hours and docetaxel 50 mg/m2 administered over 1 hour. All medications are administered intravenously via mediport.
Durvalumab 1500 mg will be administered intravenously over 1 hour according to the usual q4 week schedule - with every other chemo cycle.
On completion of adjuvant chemotherapy. Receives: Radiation: PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy; Drug: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase 2 dose (RP2D) of PULSAR
To determine the recommended phase 2 dose (RP2D) of PULSAR that produces a Dose-Limiting Toxicity (DLT) rate of 30% when interdigitated with perioperative FLOT(D) chemotherapy.
The RP2D of PULSAR will be determined by toxicity assessed by NCI CTCAE v5.0 toxicity criteria
Measured: First administration of radiotherapy (RT) to 60 days after completion of RT or day of surgery, whichever occurs first
Secondary outcomes (6)
Adverse events description per NCI CTCAE version 5.0
To describe the adverse events associated with PULSAR and perioperative FLOT(D). Adverse events will be described using the NCI CTCAE version 5.0.
Measured: Baseline until 60 days after completion of study-related activities; up to 5-years of follow-up.
Pathological response rates
To evaluate the rate of major pathologic response and complete pathologic response to PULSAR and FLOT(D) chemotherapy on the surgical sample by the Mandard criteria.
Pathological response rates will be defined histopathologically by the Mandard criteria including an assessment of tumor regression and lymph node regression
Measured: Time of enrollment to date of surgery
Overall Survival
To determine the overall survival, defined as the time between date of enrollment and the date of death or hospice enrollment
Measured: Time of enrollment to date of death or hospice; up to after the last patient entering the study has completed 5-years of follow-up
Disease-free survival
To evaluate disease-free survival, defined as the time between date of enrollment and the first date of recognized recurrence of cancer, development of a new primary cancer, or death from any cause.
Measured: Time of surgical resection until date of death, recurrence, development of new primary tumor, or hospice enrollment- up to 5-years of follow-up.
Proportion of patients who undergo R0 resection
To evaluate the R0 resection rate of patients who undergo surgery, defined as a negative surgical margin at time of resection as determined by histopathological examination.
R0 resection will be defined as the percent of participants who underwent surgery with an R0 resection, defined as negative gross and microscopic margins from the tumor sample.
Measured: Time of resection
Proportion of patients undergoing FLOT(D)+PULSAR who experience delay in surgery
To evaluate the proportion of patients undergoing FLOT(D)+PULSAR who experience delay in surgery due to recovery from toxicities.
Delay in surgery will be defined as any unplanned rescheduling of surgery from initial planned surgical date as determined by the collaborating surgical oncologist or thoracic oncologist.
Measured: Time of enrollment to date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start28 Aug 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal Junction (GEJ) CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Brown, University of Texas Southwestern Medical Center
- Investigators
- Timothy Brown, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700420
- Sponsor's protocol ID
- STU20250653
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Perioperative FLOT(D) With Neoadjuvant Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Resectable Esophageal and Gastro-esophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT07700420
- Acronym / sponsor ID
- STU20250653
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants with resectable locally advanced esophageal or gastro-esophageal junction cancer will enroll to receive perioperative FLOT or FLOT(D) (standard of care) and will receive interdigitated neoadjuvant PULSAR delivered at one of three possible dose levels in four total fractions. Following completion of neoadjuvant portion of the study, patients will undergo re-evaluation for resectability and proceed to resection if it remains feasible. Following resection, patients will complete all planned curative intent therapy with four adjuvant cycles of FLOT or FLOT(D). Those who receive FLOT(D) will subsequently receive 10 cycles of adjuvant durvalumab monotherapy per standard of care1. All patients will enter follow-up on completion of FLOT chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PULSAR radiation in combination with perioperative FLOT(D) | Experimental | Radiation: PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy, Drug: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)PULSAR radiation plus FLOT(D) Each cycle of FLOT(D) consists of 5-fluorouracil 2600 mg/m2 administered over 24 hours, leucovorin 200 mg/m2 administered over 2 hours, oxaliplatin 85 mg/m2 administered over 2 hours and docetaxel 50 mg/m2 administered over 1 hour. All medications are administered intravenously via mediport. Durvalumab 1500 mg will be administered intravenously over 1 hour according to the usual q4 week schedule - with every other chemo cycle. On completion of adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy-1 5.5 Gy x 4 Fractions 1. 6 Gy x 4 Fractions 2. 6 Gy x 4 Fractions with simultaneous boost to gross disease to 7 Gy x 4 Fractions 3. 6 Gy x 4 Fractions with simultaneous boost to gross disease to 8 Gy x 4 Fractions | Radiation | PULSAR radiation in combination with perioperative FLOT(D) |
| FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)5-fluorouracil 2600 mg/m2 leucovorin 200 mg/m2 ad oxaliplatin 85 mg/m2 docetaxel 50 mg/m2 Durvalumab 1500 mg All medications are administered intravenously via mediport. | Drug | PULSAR radiation in combination with perioperative FLOT(D) |
Primary outcome
Recommended phase 2 dose (RP2D) of PULSAR
Time frame: First administration of radiotherapy (RT) to 60 days after completion of RT or day of surgery, whichever occurs first
To determine the recommended phase 2 dose (RP2D) of PULSAR that produces a Dose-Limiting Toxicity (DLT) rate of 30% when interdigitated with perioperative FLOT(D) chemotherapy. The RP2D of PULSAR will be determined by toxicity assessed by NCI CTCAE v5.0 toxicity criteria
6 secondary outcomes
Adverse events description per NCI CTCAE version 5.0
Time frame: Baseline until 60 days after completion of study-related activities; up to 5-years of follow-up.
Pathological response rates
Time frame: Time of enrollment to date of surgery
Overall Survival
Time frame: Time of enrollment to date of death or hospice; up to after the last patient entering the study has completed 5-years of follow-up
Disease-free survival
Time frame: Time of surgical resection until date of death, recurrence, development of new primary tumor, or hospice enrollment- up to 5-years of follow-up.
Proportion of patients who undergo R0 resection
Time frame: Time of resection
Proportion of patients undergoing FLOT(D)+PULSAR who experience delay in surgery
Time frame: Time of enrollment to date of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gastro-esophageal Junction (GEJ) Cancer
RecruitingPhase 3
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
RecruitingPhase 1
Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
Breast Cancer, Non-small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 2
Neoadjuvant SHR-A1811 ± Adebrelimab in GC/GEJ
Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma
Not yet recruitingPhase 2
A Study of Trifluridine/Tipiracil (TAS-102) Combined With Nedaplatin for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Refractory to ≥ Second-Line Chemotherapy
Gastric Cancer (GC)
RecruitingPhase 2
An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma
Gastroesophageal Junction (GEJ) Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Brown, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy and FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D) in people with Gastro-esophageal Junction (GEJ) Cancer and Esophagus Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Knight (214-648-7097, Jennifer.Knight@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase 2 dose (RP2D) of PULSAR (time frame: First administration of radiotherapy (RT) to 60 days after completion of RT or day of surgery, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.