Clinical trial · Interventional
Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer
NCT01463501CI-TRIAL-00010278unknownPhase 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 is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant chemoradiotherapy | Other | — | UNRESOLVED |
| Neoadjuvant chemoradiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Treatment
- description
- Preoperative chemotherapy/radiotherapy
- interventionNames
- Other: Neoadjuvant chemoradiotherapy
- type
- EXPERIMENTAL
- label
- Adjuvant Treatment
- description
- Postoperative chemotherapy/radiotherapy
- interventionNames
- Other: Adjuvant chemoradiotherapy
Primary outcomes (2)
- measure
- Scores of Quality of life
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20cm from the incisors) or gastroesophageal junction are included. * No distant metastases (M0). * Patients will be stratified by stage (clinical N0 versus clinical N1). * Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy. * Resectable mediastinal nodes are eligible. * No prior chemotherapy for this malignancy. * No prior radiotherapy that would overlap the field(s) treated in this study. * Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer. * Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon. Exclusion Criteria: * Cancers of the cervical esophagus (\< 20 cm are excluded). * Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible. * Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible. * Patients with biopsy proven metastatic celiac nodes are ineligible.
References
Publications (0)
Data not yet available
No reference posted for this study.