Clinical trial · Interventional
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal (GEJ) Tumors: A Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is for patients who have stomach cancer or cancer of the lower part of the esophagus that has spread to other organs. There are many different chemotherapy treatments for this type of cancer. At the present time, there is no general agreement on the way to choose the most beneficial therapy for an individual patient. Patients with different genetic backgrounds may respond differently to the same chemotherapy treatments. In this study the investigators will use a certain genetic difference in an important gene (thymidylate synthase or TS gene) to see whether treating patients who have a particular type of that gene will respond better to a standard chemotherapy regimen. The investigators are hoping that by treating patients according to their genes, that they may respond to treatment of their cancer better and it will help the investigators choose cancer treatments better in the future.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxaliplatin/Leucovorin/5-FU
- description
- "Good risk" patients with the TSER\*2/\*2 or \*2/\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
- interventionNames
- Drug: 5-fluorouracil
- Drug: Oxaliplatin
- Drug: Leucovorin
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 2 years
- description
- * ORR = complete response + partial response * Complete response - disappearance of all target and non-target lesions * Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Secondary outcomes (18)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction. * Patients must have measurable disease. * No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is permitted if the disease free interval has been longer than 6 months. * Age ≥18 years. * Life expectancy of greater than 3 months. * ECOG (Eastern Cooperative Oncology Group) performance status greater than 2 (Karnofsky greater than 60%). * Patients must have normal organ and marrow function. * Not pregnant. Not breast feeding. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients may not be receiving any other chemotherapy agents. * Patients with known active brain metastases. Patients with treated brain metastases are permitted if stable off steroids for at least 30 days. * History of allergic reactions to 5-FU or oxaliplatin. * Uncontrolled intercurrent illness. * Patients with immune deficiency.
References
Publications (1)
- DERIVEDGoff LW, Thakkar N, Du L, Chan E, Tan BR, Cardin DB, McLeod HL, Berlin JD, Zehnbauer B, Fournier C, Picus J, Wang-Gillam A, Lee W, Lockhart AC. Thymidylate synthase genotype-directed chemotherapy for patients with gastric and gastroesophageal junction cancers. PLoS One. 2014 Sep 18;9(9):e107424. doi: 10.1371/journal.pone.0107424. eCollection 2014. PMID 25232828