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.
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
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.
Single group
PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy
Radiation-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
FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)
Drug5-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.
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
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.
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
Overall Survival
To determine the overall survival, defined as the time between date of enrollment and the date of death or hospice enrollment
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.
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