Clinical trial · Interventional
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
NCT04519905CI-TRIAL-00054820recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
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 |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Survival | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel plus carboplatin | Drug | — | UNRESOLVED |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- chemoradiotherapy
- description
- 50.4Gy/28Fx; Paclitaxel plus carboplatin
- interventionNames
- Drug: Paclitaxel plus carboplatin
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- radiotherapy
- description
- 61.2Gy/34Fx
- interventionNames
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- overall survival difference of definitive radiotherapy and chemoradiotherapy groups
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * Indicates no limit on eligibility based on the sex of participants * The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study. * Esophageal squamous cell carcinoma confirmed by pathology * No radiotherapy, chemotherapy or other treatments prior to enrollment * Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th) * Use of an effective contraceptive for adults to prevent pregnancy * No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function * No immunodeficiency * ECOG 0-1. * Life expectancy of more than 3 months. Exclusion Criteria: * Total radiotherapy dose cannot reach 61.2Gy/34Fx * Esophageal perforation, or hematemesis * History of radiotherapy or chemotherapy for esophageal cancer * History of surgery within 28 days before Day 1 * History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years) * Participation in other interventional clinical trials within 30 days * Pregnant or breast-feeding women or fertile patients * Drug addiction, * alcoholism or AIDS * Uncontrolled seizures or psychiatric disorders
References
Publications (0)
Data not yet available
No reference posted for this study.