Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
A Nonrandomized Phase II Study: Feasibility and Outcome of Neo Adjuvant Chemotherapy With Oxaliplatin, Fluorodeoxyuridine (FUdR), Taxotere and Leucovorin in the Treatment of Previously Untreated Advanced Esophago-Gastric Carcinoma
- 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)
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.
Conditions
Conditions (1)
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional surgery | Procedure | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Floxuridine | Drug | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Microarray analysis | Genetic | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant + Adjuvant Chemotherapy
- interventionNames
- Drug: Docetaxel
- Drug: Floxuridine
- Drug: Leucovorin
- Drug: Oxaliplatin
- Genetic: Microarray analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Procedure: Conventional surgery
Primary outcomes (1)
- measure
- Pathologic Complete Response
- timeFrame
- 8 - 16 weeks
- description
- No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.
Secondary outcomes (3)
- measure
- Clinical Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the esophagus meeting the following criteria: * Stage II or III disease * Resectable disease * Previously untreated disease * No stage I (mucosal only) or stage IV (metastatic) disease PATIENT CHARACTERISTICS: * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Bilirubin \< 2 times normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must have central venous access * No other malignancy within the past 5 years * No concurrent medical or psychiatric problem that would preclude study treatment * No contraindications to paclitaxel PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy to the esophagus * No oral cryotherapy (e.g., ice chips) on day 1 of each course
References
Publications (1)
- RESULTSolomon N, Mezentsev D, Reis I, Lima M, Rios J, Avisar E, Franceschi D, Livingstone A, Podolsky L, Ardalan B. A phase II study of neoadjuvant and adjuvant chemotherapy with 5-fluorodeoxyuridine, leucovorin, oxaliplatin and docetaxel in the treatment of previously untreated advanced esophageal adenocarcinoma. Jpn J Clin Oncol. 2011 Apr;41(4):469-76. doi: 10.1093/jjco/hyq239. Epub 2011 Jan 21. PMID 21258083