Combination Therapy for Esophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil followed by surgery and response based concurrent chemotherapy and radiation therapy works in treating patients with cancer of the esophagus, gastroesophageal junction, or gastric cardia. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving chemotherapy followed by surgery and response based chemotherapy and radiation therapy may kill more tumor cells.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had prior chemotherapy, radiation, or surgery for this cancer, and you cannot be on any other investigational therapy.
Is the combination therapy for esophageal cancer safe for humans?
What makes the combination therapy for esophageal cancer unique?
This treatment combines three drugs—fluorouracil, leucovorin, and oxaliplatin—with surgery, which is different from the more common use of fluorouracil and cisplatin. The addition of oxaliplatin and the surgical approach may offer a new option for patients, especially those who have developed resistance to standard chemotherapy.23678
What data supports the effectiveness of the treatment for esophageal cancer?
Research shows that combining oxaliplatin, 5-fluorouracil, and leucovorin with radiotherapy is effective and safe for treating advanced esophageal cancer. Additionally, the combination of leucovorin, 5-fluorouracil, and oxaliplatin (FOLFOX) has been evaluated for its efficacy in treating esophageal squamous cell carcinoma after surgery.23679
Who Is on the Research Team?
Michael McNamara, MD
Principal Investigator
Case Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with specific cancers of the esophagus, gastroesophageal junction, or gastric cardia. They must be in good physical condition (ECOG 0-1), have adequate blood counts and organ function, and no severe neuropathy. Pregnant women, those with distant metastasis or another active cancer (with some exceptions), prior treatments for this cancer, certain infections like hepatitis B/C or HIV, serious heart conditions, or other medical issues that could affect participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil over 44 hours on days 1-3, repeated every 14 days for up to 4 courses
Surgery
Approximately 4-5 weeks after completion of induction chemotherapy, patients undergo a surgical procedure
Adjuvant Therapy
Within 6-12 weeks after surgery, patients undergo radiation therapy for 28 days. Additional chemotherapy is given based on pathological response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Fluorouracil
- Leucovorin Calcium
- Oxaliplatin
- Paclitaxel
- Radiation Therapy
- Therapeutic Conventional Surgery
Fluorouracil is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor