Clinical trial · Interventional
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study
NCT03579004CI-TRIAL-00033648unknownPhase 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)
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma
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 |
|---|---|---|---|
| Concurrent Chemoradiotherapy | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiotherapy | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Ivor Lewis esophagogastrectomy | Procedure | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trimodality approach
- description
- 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
- interventionNames
- Drug: Paclitaxel
- Drug: Cisplatin
- Drug: Fluorouracil
- Radiation: chemoradiotherapy
- Procedure: Ivor Lewis esophagogastrectomy
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 24 months
- description
- Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. age 18-75 2. Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed 3. No prior antineoplastic treatment 4. Eastern Cooperative Oncology Group (ECOG) status 0-2 5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy * absolute neutrophil count ≥ 1,500 х109/l * thrombocytes ≥ 100 х 109/l * hemoglobin ≥ 90 mg/l * creatinine \< 115 µmol/л or creatinine clearance ≥ 55 ml/min * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN) * alkaline phosphatase (ALP) \> 5 x ULN * bilirubin \> 1,5 х ULN 6. Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment 7. Patients must follow appropriate contraception rules during whole treatment period 8. Decrease of body weight must not be more than 20% in last 6 months Exclusion Criteria: 1. Presence of distant metastases except for metastatic supraclavicular lymphnodes; 2. Bulky (\>3 cm) regional lymphnodes metastases; 3. Cervical esophageal cancer; 4. Presence of tumor fistula; 5. Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer; 6. Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
References
Publications (0)
Data not yet available
No reference posted for this study.