Induction FLOT With CROSS CRT for Esophageal Cancer (NCT04028167) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Induction FLOT With CROSS CRT for Esophageal Cancer
United States40 participantsStarted 2020-04-08
Plain-language summary
This study evaluates a novel regimen of induction chemotherapy using a combination of docetaxel, oxaliplatin, and leucovorin, with short term infusional 5-FU (FLOT), given prior to chemoradiotherapy with concurrent carboplatin and paclitaxel, as neoadjuvant therapy prior to definitive surgical resection for patients with adenocarcinoma of the esophagus or gastroesophageal junction
Who can participate
Age range
18 Years – 100 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
. Provision to sign and date the consent form.
. Stated willingness to comply with all study procedures and be available for the duration of the study.
. Be a male or female aged 18-100.
. Have newly diagnosed, resectable cT3-T4 or node positive adenocarcinoma of the esophagus or gastroesophageal junction as assessed by CT or MRI of the chest, abdomen and pelvis and by endoscopic ultrasound, with pathologic diagnosis obtained within 3 months of signing consent, without delivery of prior chemotherapy or radiation therapy.
. Subjects must be previously untreated with systemic chemotherapy or radiation therapy.
. Subjects must be deemed a candidate for trimodality therapy (radiation, chemotherapy and surgery) based upon multidisciplinary evaluation with plan for preoperative chemoradiation followed by surgical resection.
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
Evaluate the rate of pathologic complete response (pCR) to the study regimen.
. ECOG performance status score of 0-1 (See Appendix).
. Adequate bone marrow function (WBC \> 3 x 109/L; hemoglobin \> 9 g/dl; platelets \> 100 x 109/L)
Exclusion criteria
. Subjects with metastatic or inoperable esophageal or gastroesophageal junction adenocarcinoma.
. Subjects with esophageal or gastroesophageal junction squamous cell carcinoma or adenosquamous carcinoma.
. Prior treatment with chemotherapy or radiation therapy for esophageal or gastroesophageal adenocarcinoma.
. Prior malignancy active within the previous 3 years that is felt to exclude the patient from definitive therapy of esophageal or gastroesophageal cancer, or if prior cancer therapy is felt by the investigator to significantly increase toxicity risk from the study regimen.
. Prior history of thoracic or abdominal radiotherapy that would overlap with the planned treatment volume.
. Active collagen vascular disease.
. Subjects with \> Grade 1 peripheral neuropathy.
. Any serious or uncontrolled medical disorder or active infection, that in the opinion of the investigator may increase the risk associated with study participation, study treatment administration or would impair the ability of the subject to receive study treatment.