Clinical trial · Interventional
RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus
Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.
NCT00559351CI-TRIAL-00000983terminatedPhase 3ClinicalTrials.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): difficulty in recruitment
Summary
Brief summary (as posted)
The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.
Conditions
Conditions (2)
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 Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Cancer | Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemoradiotherapy | Radiation | — | UNRESOLVED |
| neoadjuvant chemotherapy (cisplatin, 5-fluorouracil) | Drug | — | UNRESOLVED |
| transthoracic esophagectomy 2-field extended lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- S
- description
- esophagectomy
- interventionNames
- Procedure: transthoracic esophagectomy 2-field extended lymphadenectomy
- type
- EXPERIMENTAL
- label
- CHTS
- description
- neoadjuvant chemotherapy followed by esophagectomy
- interventionNames
- Drug: neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)
- type
- EXPERIMENTAL
- label
- CHRTS
- description
- neoadjuvant chemoradiotherapy followed by esophagectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus * Patients' age above 18 years * General condition with Karnofsky performance status of \>70 * Circulatory and pulmonary capacity at normal range (FEV1 \>60%; FVC \>60%, NYHA I-II, cardiac output \>40%) * Normal function of the bone marrow (RBC \>3,5 T/l; PLT \>100 G/l) * Normal renal (creatinine \<1.5 of the upper limit) and liver (AST or ALT \<2,5 of the upper limit or bilirubin \<1,5 of the upper limit) function Exclusion Criteria: * Metastatic disease * Synchronous malignancy * History of other cancer within 5 years prior to esophageal cancer treatment * History of allergic reaction to cisplatin of 5-fluorouracil * Systemic infection * Pregnancy or female patients in childbearing age without proper contraceptives.
References
Publications (0)
Data not yet available
No reference posted for this study.