Gastro-esophageal Junction (GEJ) Cancer study: FLOT
Official title Perioperative FLOT(D) With Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Esophageal Cancer
ClinicalTrials.gov ID: NCT07700420
What this study is testing
What is FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)?
FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D) is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for gastro-esophageal junction (gej) cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding PULSAR radiation to standard chemotherapy and immunotherapy is safe and what radiation dose is safest.
- Who it's for
- You may be able to join if you have esophageal or gastro‑esophageal junction cancer and are receiving standard chemo and immunotherapy.
- What's involved
- You will get the usual chemo and immunotherapy plus extra radiation treatments. You will have extra visits and checks for the radiation.
- Time commitment
- The study runs during your regular treatment period with additional radiation visits.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- 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.
You likely can't join if
- 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.
- 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...
- Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would...
See the full eligibility 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.
- 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.
- 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...
- 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).
- 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).
- 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...
- 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.
- 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...
- 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...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to FLOT chemotherapy, durvalumab or other agents used in study.
- people 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.
- 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).
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.