Clinical trial · Observational
Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal Cancer
A Phase II Study of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin in Inoperable Esophageal Cancer
NCT01640860CI-TRIAL-00007447completedClinicalTrials.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)
This study is designed to determined the feasibility and safety in advanced esophageal cancer treated with docetaxel and cisplatin cocurrent chemoradiotherapy. The primary end points were clinical best response and response rate and secondary endpoints were progression free survival and overall survival.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 4-6 weeks after completion of CRT
- description
- Chest and abdominal CT and EGD were obtained to assess tumor status, 4 to 6 weeks after the completion of CRT. The patients who were documented on the CT scan and upper gastrofibroscopy as showing a complete response (CR) underwent positron emission tomography (PET)-CT. If the PET-CT showed no metabolic evidence of malignancy, we deemed the response to be a CR.
Secondary outcomes (1)
- measure
- progression free survival, overall survival and adverse events
- timeFrame
- every 3-6 months
- description
- Tumor resection with extended en bloc lymphadenectomy was performed in operable patients approximately 4 to 8 weeks after treatment. Follow-up evaluation was performed every 3months for the first 2years, then every 6monhs for the next 3 years, then annually until patinet death or loss to follow-up. This included clinical examination, dysphagia score, assessment of late radiation toxicity and repeat CT scan of chest/ abdomen and EGD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18\<age\<75 years 2. histologically proven and previously untreated SCC of the esophagus 3. WHO performance status(PS)≤2 4. absolute neutrophil count≥2,000/uL, platelet count≥100,000/uL 5. adequate renal and hepatic function 6. No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed 7. No prior radiation therapy for at least 4 weeks before enrollment in the study Exclusion Criteria: 1. Evidence of distant metastases 2. Pleural of pericardial effusion 3. Fistulisation 4. Prior malignancies(other than basal cell skin carcinoma) 5. Prior myocardial infarction or uncontrolled infection 6. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry 7. History of significant neurologic or psychiatric disorders including dementia or seizures 8. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.