Clinical trial · Interventional
Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
An Oxaliplatin-Based Phase II Randomized Study of Induction Chemotherapy Followed by Preoperative Chemoradiotherapy or Preoperative Chemoradiotherapy in Patients With Resectable Esophageal or Gastroesophageal 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)
The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared. Objectives: Primary objective: Compare the Pathologic Complete Response rate and % of patients with \<50% residual cancer in the resected surgical specimen between Arms A and B. Secondary objectives: 1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B 2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome. 3. Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastroesophageal Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Chemo with Radiation Treatment
- description
- For 5 weeks, Chemo of 5-FU 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Oxaliplatin
- Radiation: Radiation Therapy
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Arm B: Pre-Op Chemo + Chemo with Radiation Treatment
- description
- Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Oxaliplatin
- Radiation: Radiation Therapy
- Procedure: Surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: 1. Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction. 2. Patients with T1N1, and T2-3 with any N (M1a only) will be eligible. 3. Normal liver (serum glutamic-pyruvic transaminase (SGPT) \< 56µL, Total Bilirubin \<1.5 mg/dL), kidney (Creatinine \<1.75 mg/dL), and bone marrow functions (AGN \>1,500µL, platelet count \>100,000/µL). 4. Performance status 0 or 1. 5. Signed informed consent by the investigator or their designee and patient. 6. Medically fit for surgery. 7. No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative. 8. None of the celiac nodes should be larger than 2 cm 9. Male or Female but both sexes must practice adequate contraception while on therapy 10. \>/=18 years but less than 76 years 11. No known allergy to any of the study drugs. 12. No prior therapy for this cancer. 13. No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years 14. New York Heart Association (NYHA) I and II Exclusion Criteria: 1. Patients with T1N0, T4, or M1b cancer will be excluded 2. Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance). 3. More than grade 1 neuropathy 4. Unable to comprehend the requirements of the study or comply with it.
References
Publications (3)
- DERIVEDShimodaira Y, Slack RS, Harada K, Chen HC, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Blum MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Mares J, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Influence of induction chemotherapy in trimodality therapy-eligible oesophageal cancer patients: secondary analysis of a randomised trial. Br J Cancer. 2018 Feb 6;118(3):331-337. doi: 10.1038/bjc.2017.423. Epub 2017 Dec 12. PMID 29235564
- DERIVEDHarada K, Wang X, Shimodaira Y, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Lopez A, Blum Murphy MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Early Metabolic Change after Induction Chemotherapy Predicts Histologic Response and Prognosis in Patients with Esophageal Cancer: Secondary Analysis of a Randomized Trial. Target Oncol. 2018 Feb;13(1):99-106. doi: 10.1007/s11523-017-0540-3. PMID 29218623
- DERIVEDAjani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23. PMID 23975663