A Phase I Trial of Perioperative FLOT(D) With Neoadjuvant Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Resectable Esophageal and Gastro-esophageal Junction Cancer
University of Texas Southwestern Medical Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Willing and able to provide written informed consent. 3. 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) 4. T1N+ or T2-4N(any) by the American Joint Committee on Cancer stagi…
Interventions
- RadiationPULSAR- 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
- DrugFLOT (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.
Location
- University of Texas Southwestern Medical CenterDallas, Texas