Clinical trial · Interventional
Molecular Phenotyping in Predicting Response in Patients With Stage IB-III Esophageal Cancer Receiving Combination Chemotherapy
Pilot Study of Correlation Between Molecular Phenotype and Response to Two Independent Treatment Regimens, Carboplatin and Paclitaxel vs. 5-Fluorouracil and Oxaliplatin Chemotherapy in Patients With Localized Esophageal Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This randomized pilot phase II trial studies how well molecular phenotyping works in predicting response in patients with stage IB-III esophageal cancer who are receiving carboplatin and paclitaxel or oxaliplatin, leucovorin calcium, and fluorouracil. Studying the genes in a patients tumor cells before and after chemotherapy may help in understanding if there are specific features of the tumor cells that make a person more or less likely to respond to treatment and how these features may be affected by treatment.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IB Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage IIB Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage IIIC Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Leucovorin Calcium | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (paclitaxel, carboplatin, radiation therapy, surgery)
- description
- INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks). CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday). SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Radiation: Radiation Therapy
- Procedure: Therapeutic Conventional Surgery
- Other: Laboratory Biomarker Analysis
- type
- EXPERIMENTAL
- label
- Arm II (combination chemotherapy, radiation therapy, surgery)
- description
- INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks). CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks. SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed localized (T1N1-3M0 or T2-4NanyM0, stage IB-III) Siewert type 1 or type 2 esophageal adenocarcinoma that is amenable to surgical resection as determined by a thoracic surgeon and for which all disease (primary tumor and involved lymph nodes) can be treated with radiation, as determined by a radiation oncologist * Patients may not have received any prior chemotherapy, biologic therapy or radiation therapy for management of their disease; chemotherapy or biologic therapy administered for treatment of another primary malignancy are permitted if treatment was greater than 5 years ago * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Patients must have a life expectancy of \> 3 months, in the opinion of and as documented by the investigator * Hemoglobin \>= 10.0 g/dl * Absolute neutrophil count \>= 1,500/mcL * Platelet count \>= 100,000/mcL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 X institutional upper limit of normal * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal * Serum creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (as calculated by Cockcroft-Gault) * Patients must have an avid primary tumor with an standardized uptake value (SUV) of \>= 5 on baseline (18F) FDG-PET/computed tomography (CT) imaging * Men must agree to use adequate contraception (double barrier method of birth control or abstinence) 1 week prior to study entry, for the duration of study participation and for 1 month after completing combined modality treatment with chemotherapy and radiation; should a male patient's female partner become pregnant or suspect that she is pregnant while her partner is participating in this study, the treating physician should be informed immediately * Patients must have the ability to understand and the willingness to sign a written informed consent document * This study will be limited to enrollment of Caucasian males only Exclusion Criteria: * Patients who are receiving any chemotherapy, biologic therapy, radiation therapy or any investigational agent * Patients with metastatic disease * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to platinums, taxanes or fluoropyrimidines * Patients who have previously received radiation therapy to the chest or abdomen such that there would be overlap between the previous and current radiation field * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with human immunodeficiency virus (HIV) whom are not receiving antiretroviral therapy * Patients with another malignancy within the past 5 years
References
Publications (0)
Data not yet available