Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Rese… (NCT04097028) | Clinical Trial Compass
CompletedPhase 2
Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma
United States22 participantsStarted 2019-12-20
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have histologically proven loco-regional esophageal or gastroesophageal junction adenocarcinoma
* Endoscopic ultrasound (EUS), or clinically determined node-positive disease with any T-stage or T3-T4a with any N stage: Patients with EUS T4b and any M1 cancer will not be included
* Must have potentially resectable disease
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Hemoglobin \>= 9 g/dL
* Absolute neutrophil count \>= 1500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Creatinine \< 1.5 upper limit of normal (ULN)
* Bilirubin \< 1.5 x ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN
* Capacity to take oral tablet(s) without difficulty
* Participants of child-bearing potential must agree to use highly effective contraceptive methods (e.g., hormonal plus barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Prior chemotherapy, thoracic radiotherapy or prior surgical resection for an esophageal tumor
* Participants with known metastatic disease
* Any concurrent activ…
What they're measuring
1
Number of Patients With a Pathologic Complete Response
Timeframe: Assessed at the time of surgery (approximately 6 months after start of neoadjuvant therapy)