Clinical trial · Interventional
S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
NCT02913066CI-TRIAL-00028149unknownPhase 2ClinicalTrials.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)
Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy. Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.
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 Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 concurrent radiotherapy | Other | — | UNRESOLVED |
| S-1 plus Cisplatin concurrent radiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single drug
- description
- S-1 concurrent Radiotherapy
- interventionNames
- Other: S-1 concurrent radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Double drug
- description
- S-1 plus cisplatin concurrent Radiotherapy
- interventionNames
- Other: S-1 plus Cisplatin concurrent radiotherapy
Primary outcomes (1)
- measure
- Complete Remission Rate (CR)
- timeFrame
- Three months after radiotherapy finished
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histology or cytology confirmed esophageal squamous cell carcinoma. 2. There are measurable lesions in the RECIST standard. 3. American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a\~ IV B period. 4. Age younger than 75 years old. 5. Eastern Cooperative Oncology Group physical status score was 0 \~ 1. 6. No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion. 7. Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before. 8. Serum hemoglobin is\<100g/L, platelet\>100 \* 109/L,Absolute neutrophil count\>1.5 \* 109/L. 9. Cr≤1.25 upper normal limit or CCr≥60 mL/min. 10. Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit. 11. A history of interstitial pneumonia and interstitial pneumonia. 12. FEV1\>0.8 liters. 13. Patients or family members signed a formal informed consent. Exclusion Criteria: 1. Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer. 2. Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm. 3. Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia. 4. Patients with distant metastases. 5. There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation. 6. Can't understand the test requirements, or patients may not comply with the requirements of the test. 7. There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years. 8. An allergic reaction known to have 3 or 4 levels of any treatment. 9. Had participated in other clinical trials in the past 30 days. 10. The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.
References
Publications (1)
- DERIVEDZhao Z, Wen Y, Liao D, Miao J, Gui Y, Cai H, Chen Y, Wei M, Jia Q, Tian H, Sun M, Zhang Y, Feng G, Du X. Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1900-e1908. doi: 10.1634/theoncologist.2020-0808. Epub 2020 Sep 28. PMID 32864805