Clinical trial · Interventional
S-1 and Radiotherapy for Elderly Esophageal Cancer Patients
A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients
NCT02716688CI-TRIAL-00069874withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients enrolled.
Summary
Brief summary (as posted)
To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.
Conditions
Conditions (3)
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 |
| Radiotherapy | — | UNRESOLVED | — |
| S-1 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy and S-1 arm
- description
- Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.
- interventionNames
- Drug: S-1
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- response rate
- timeFrame
- week 4
- description
- Response rate will be done after 4 weeks following the last radiotherapy session.
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cytologically or histologically confirmed esophageal carcinoma; 2. ECOG performance status: 0-1; 3. No treatments prior to enrollment; 4. At least one measurable lesion on CT, MRI or esophageal barium exam; 5. Normal functions of heart, lung, liver, kidney and bone marrow; 6. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL; 7. Informed consent signed. Exclusion Criteria: 1. Prior treatments of chemotherapy or irradiation; 2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable; 3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis; 4. Participating in other clinical trials; 5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities; 6. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
References
Publications (0)
Data not yet available
No reference posted for this study.