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 range18 Years – 100 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Evaluate the rate of pathologic complete response (pCR) to the study regimen.
✕. 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.