Clinical trial · Interventional
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
- 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 capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy 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 giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination Therapy - Capecitabine | Drug | — | UNRESOLVED |
| Combination Therapy - Oxaliplatin | Drug | — | UNRESOLVED |
| Combination Therapy - Radiation | Radiation | — | UNRESOLVED |
| Evaluation for response and surgery | Procedure | — | UNRESOLVED |
| Induction Therapy - Capecitabine | Drug | — | UNRESOLVED |
| Induction Therapy - Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction, Combination and surgery
- description
- Weeks 1-6: Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8 Weeks 7-12: Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday Evaluation for response and resection surgery
- interventionNames
- Drug: Induction Therapy - Capecitabine
- Drug: Induction Therapy - Oxaliplatin
- Drug: Combination Therapy - Capecitabine
- Drug: Combination Therapy - Oxaliplatin
- Radiation: Combination Therapy - Radiation
- Procedure: Evaluation for response and surgery
Primary outcomes (1)
- measure
- Determine Pathologic Complete Response
- timeFrame
- At time of surgery
- description
- Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections. Pathologic response will be defined as: P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction * Stage I-IVA disease * No distant metastatic disease (other than regional lymph nodes) * No evidence of CNS metastases * CNS metastases stable for \> 3 months allowed PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Consuming ≥ 1,500 calories daily * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No pre-existing neuropathy * No prior unanticipated severe reaction to fluoropyrimidine therapy * No known hypersensitivity to fluorouracil * No known DPD deficiency * No known hypersensitivity to any of the components of oxaliplatin * No significant active infection or other severe complicated medical illness * No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) * No myocardial infarction within the past 12 months * No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake * No malabsorption syndrome * No other active malignancy within the past 3 years except cervical carcinoma in situ or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior participation in any investigational drug study * No prior pelvic or thoracic radiotherapy
References
Publications (0)
Data not yet available