Chemotherapy + Radiation for Esophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Do I need to stop my current medications to join the trial?
The protocol does not specify if you need to stop your current medications. However, since the trial involves chemotherapy and radiation, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.
What safety data exists for chemotherapy and radiation treatment for esophageal cancer?
The safety data for chemotherapy and radiation treatment, including regimens like FLOT and CROSS, show varying levels of toxicity. The FLOT regimen, which includes 5-FU, leucovorin, oxaliplatin, and docetaxel, is noted for its effectiveness but also for significant toxicity, with up to 50-70% of patients experiencing grade 3-4 neutropenia. The CROSS regimen, used for neoadjuvant chemoradiotherapy, achieves good locoregional response rates. A phase II study of definitive chemoradiotherapy using docetaxel and 5-fluorouracil reported mild hematologic toxicity and some nonhematologic adverse events like esophagitis and anorexia, but no treatment-related deaths. Overall, while these treatments are effective, they are associated with notable toxicities, and further trials are needed to develop less toxic strategies.12345
Is Sequential FLOT a promising drug for esophageal cancer?
What data supports the idea that Chemotherapy + Radiation for Esophageal Cancer is an effective treatment?
The available research shows that Chemotherapy + Radiation, specifically the CROSS regimen, is effective for treating esophageal cancer. It achieves a good local response, with up to 33% of patients experiencing a complete response, meaning the cancer is no longer detectable. When compared to the FLOT regimen, which is another chemotherapy approach, CROSS is noted for its effectiveness in managing locally advanced esophageal cancer. Additionally, the FLOT regimen is highlighted for improving survival rates in patients with esophagogastric cancer, suggesting that both treatments have their strengths in different aspects of cancer management.24568
Who Is on the Research Team?
Jeffrey Olsen, M.D.
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed, resectable esophageal or gastroesophageal junction adenocarcinoma who haven't had chemotherapy or radiation. They must be fit enough for triple therapy (chemo, radiation, surgery), have proper kidney and liver function, and not be pregnant. Contraception is required during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive induction chemotherapy using a combination of docetaxel, oxaliplatin, leucovorin, and short-term infusional 5-FU (FLOT)
Neoadjuvant Chemoradiation
Participants undergo chemoradiotherapy with concurrent carboplatin and paclitaxel as neoadjuvant therapy
Surgical Resection
Definitive surgical resection is performed for patients with adenocarcinoma of the esophagus or gastroesophageal junction
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of pathologic complete response and survival outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Chemoradiation
- Sequential FLOT
Sequential FLOT is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
American Cancer Society, Inc.
Collaborator
Cancer League of Colorado
Collaborator
National Cancer Institute (NCI)
Collaborator