Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Trial
Official title:
Use of Trifluridine/Tipiracil (TAS-102) and Oxaliplatin as Induction Chemotherapy in Resectable Esophageal and Gastroesophageal Junction (GEJ) Adenocarcinoma
This phase II trial studies how well trifluridine/tipiracil and oxaliplatin work as the first line of treatment (induction) in treating patients with esophageal or gastroesophageal junction adenocarcinoma that can be removed by surgery (resectable). Drugs used in chemotherapy, such as trifluridine/tipiracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVE: -Evaluate the pathologic complete response (path CR) rate in participants with esophageal and gastroesophageal junction (GEJ) adenocarcinoma when trifluridine and tipiracil hydrochloride (trifluridine/tipiracil [TAS-102]) and oxaliplatin are used as induction chemotherapy prior to surgical resection. SECONDARY OBJECTIVES: - Evaluate the 2-year disease-free survival (DFS) and the 2-year overall survival (OS) - To determinate the safety and tolerability of induction chemotherapy with trifluridine/tipiracil (TAS 102) and oxaliplatin followed by standard chemoradiation and surgery - Evaluate the metabolic response to induction chemotherapy with TAS 102 and oxaliplatin in participants with esophageal and gastroesophageal junction (GEJ) adenocarcinoma prior to standard chemoradiation and surgical resection EXPLORATORY OBJECTIVE: -Correlate circulating tumor deoxyribonucleic acid (DNA) levels with disease recurrence and metabolic response on positron emission tomography (PET) computed tomography (CT). OUTLINE: Patients receive oxaliplatin intravenously (IV) over 2 hours on day 1 and trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. After completion of study treatment, patients are followed up every 3-6 months for years 1-2, every 6-12 months for years 3-5, and then annually thereafter. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04522336 -
Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer
|
Phase 1 | |
Recruiting |
NCT06078709 -
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03641313 -
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer
|
Phase 2 | |
Not yet recruiting |
NCT05296005 -
Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers
|
Phase 1 | |
Suspended |
NCT03604991 -
Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
|
Phase 2/Phase 3 | |
Recruiting |
NCT05733000 -
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05651594 -
Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
Recruiting |
NCT05269381 -
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03801876 -
Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
|
Phase 3 | |
Recruiting |
NCT04391049 -
Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery
|
Phase 1 | |
Recruiting |
NCT04660760 -
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03776487 -
Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT06203600 -
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04929392 -
Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer
|
Phase 2 | |
Recruiting |
NCT05677490 -
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
|
Phase 3 | |
Recruiting |
NCT03784326 -
Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma
|
Phase 2 | |
Recruiting |
NCT05041153 -
Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma
|
Early Phase 1 | |
Recruiting |
NCT04007744 -
Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05836584 -
Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer
|
Phase 2 | |
Recruiting |
NCT04704661 -
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Patients With Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
|
Phase 1 |