Induction FLOT With CROSS CRT for Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT04028167|
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma Esophagus Adenocarcinoma of the Gastroesophageal Junction||Drug: Sequential FLOT followed by chemoradiation||Phase 2|
Clinical outcomes following standard of care therapy for resectable esophageal and gastroesophageal junction adenocarcinoma are suboptimal, with low rates of pathologic complete response (pCR) to current neoadjuvant treatment strategies. Although significant progress has been made by incorporation of neoadjuvant chemoradiation or perioperative chemotherapy, most patients will ultimately develop disease recurrence, with both locoregional and distant recurrence representing a significant component of failure. For patients receiving preoperative chemoradiation, a regimen consisting of concurrent carboplatin and paclitaxel with radiotherapy has been established as a standard of care based on the Chemoradiotherapy for Esophageal Cancer Followed by Surgery Study (CROSS). In the long term results of CROSS, locoregional progression was noted in 22% of patients receiving neoadjuvant therapy, with distant progression in 39%.
Recent studies have also suggested perioperative chemotherapy as a potential alternative strategy for selected patients, based on results of the MAGIC trial, which included a subset patients with esophageal/GE junction tumor location, and demonstrated improved survival for patients receiving perioperative epirubicin, cisplatin, and infusional 5-fluorouracil (ECF) compared to surgery alone. The FLOT4-AIO trial has subsequently demonstrated a further overall survival benefit to a perioperative regimen of docetaxel, oxaliplatin, and leucovorin, with short term infusional 5-FU (FLOT) compared to ECF. A regimen of perioperative FLOT is currently being compared to preoperative chemoradiotherapy using the CROSS regimen in the ongoing ESOPEC trial (NCT02509286).
Given the significant risk of recurrence either with the CROSS preoperative chemoradiation regimen, or the perioperative FLOT regimen, it is plausible that selected patients may benefit from a combination of intensified systemic therapy using the FLOT backbone, in combination with sequential preoperative chemoradiation due to the known risk of locoregional recurrence in this population. This study evaluates the proposed neoadjuvant regimen of induction FLOT followed by neoadjuvant chemoradiation in patients with resectable cT3/T4 or node positive adenocarcinoma of the esophagus or gastroesophageal junction.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients With Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||April 19, 2024|
|Estimated Study Completion Date :||April 2025|
Experimental: Sequential FLOT followed by chemoradiation
Sequential Chemotherapy with Docetaxel, Oxaliplatin, and 5-Fluorouracil/Leucovorin followed by chemoradiation with concurrent carboplatin and paclitaxel
Drug: Sequential FLOT followed by chemoradiation
Chemotherapy with Docetaxel, Oxaliplatin, and 5-Fluorouracil/ Leucovorin
- Evaluate the rate of pathologic complete response (pCR) to the study regimen. [ Time Frame: 5 years ]The percentage of pathologic complete response at resection for patients who has completed the study regimen of induction FLOT, CROSS regimen chemoradiation, and surgical resection
- To determine estimates of the 1-year overall survival and disease-free survival among patients treated with the study regimen. [ Time Frame: 5 years ]The endpoint of overall survival will be defined by the proportion of evaluable patients that are living at a 1-year time interval from initial pathologic diagnosis. The endpoint of disease-free survival will be defined by the proportion of evaluable patients that are living and free of cancer recurrence at a 1-year time interval from initial pathologic diagnosis
- To describe toxicity of the study regimen as a component of neoadjuvant therapy for the study population. [ Time Frame: 5 years ]The proportion of patients experiencing any ≥grade 3 and ≥grade 4 toxicity as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be recorded.
- Patient reported quality of life [ Time Frame: 5 years ]Patient reported quality of life outcomes using the validated European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
- Measurement of change in the SUVmax on FDG-PET following induction FLOT, compared to initial diagnosis, and describe change in SUVmax among patients with and without a pCR to neoadjuvant therapy. [ Time Frame: 5 years ]Percentage reduction in SUVmax from the baseline to the post-chemotherapy PET.
- Measurement of ctDNA to generate initial descriptive data regarding ctDNA kinetics as a potential measure of treatment response [ Time Frame: 5 years ]The sensitivity and specificity of detectable ctDNA postoperatively to predict 1 year disease-free survival within the study cohort.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028167
|Contact: Robyn Swingemail@example.com|
|Contact: Emily Berensfirstname.lastname@example.org|
|United States, Colorado|
|UCHealth Memorial Hospital South||Recruiting|
|Colorado Springs, Colorado, United States, 80909|
|Contact: Angie Valdez, BS 719-365-6665|
|UCHealth Memorial Hospital North||Recruiting|
|Colorado Springs, Colorado, United States, 80920|
|Contact: Sarah Tarver 719-364-0058 email@example.com|
|UCH Lone Tree||Recruiting|
|Lone Tree, Colorado, United States, 80124|
|Contact: Lisa Lopez firstname.lastname@example.org|