Clinical trial · Interventional
Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
NCT02586753CI-TRIAL-00019573unknownPhase 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)
The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus 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 |
|---|---|---|---|
| Paclitaxel plus Cisplatin with radiotherapy | Other | — | UNRESOLVED |
| S1 plus Cisplatin with radiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel plus Cisplatin with radiotherapy
- description
- patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin
- interventionNames
- Other: Paclitaxel plus Cisplatin with radiotherapy
- type
- EXPERIMENTAL
- label
- S1 plus Cisplatin with radiotherapy
- description
- patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin
- interventionNames
- Other: S1 plus Cisplatin with radiotherapy
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically proven squamous cell carcinoma of esophagus . 2. Locally advanced esophageal cancer , with no operation indication 3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer 4. Subjects haven't been given neither radiotherapy nor chemotherapy before 5. Age of 18-70 6. PS ≦2 7. Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl 8. With no difficulty in eating 9. Expected lifetime ≧3 months Exclusion Criteria: 1. Invasion to surrounding organ ( T4 disease ) . 2. Distant metastasis , except M1a disease . 3. Complete obstruction of the esophagus, or patients who have the potential to develop perforation 4. Women in status of pregnancy 5. Patients who have complications exist as following: * Uncontrolled angina and heart failure, have a history of hospitalization in 3 months * A history of myocardial infarction in the past 6 months * There is a need for antibiotic treatment of acute bacterial or fungal infection * Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization * Drug addiction, alcoholism and AIDS disease or long-term virus carriers * Uncontrollable seizures, or loss of insight because of mental illness
References
Publications (1)
- BACKGROUNDConroy T, Yataghene Y, Etienne PL, Michel P, Senellart H, Raoul JL, Mineur L, Rives M, Mirabel X, Lamezec B, Rio E, Le Prise E, Peiffert D, Adenis A. Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer. Br J Cancer. 2010 Oct 26;103(9):1349-55. doi: 10.1038/sj.bjc.6605943. Epub 2010 Oct 12. PMID 20940718