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| ID | Type | Description | Link |
|---|---|---|---|
| PL SCSR 6P05C01320 |
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difficulty in recruitment
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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.
The choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. Surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. One of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S | Active Comparator | esophagectomy |
|
| CHTS | Experimental | neoadjuvant chemotherapy followed by esophagectomy |
|
| CHRTS | Experimental | neoadjuvant chemoradiotherapy followed by esophagectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transthoracic esophagectomy 2-field extended lymphadenectomy | Procedure | right thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck |
| Measure | Description | Time Frame |
|---|---|---|
| mean, median, 1-year, 3-year, 5-year overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| toxicity-related morbidity and mortality | 30-day | |
| postoperative morbidity and mortality | 30-day | |
| clinical and pathological response rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grzegorz Wallner, MD, PhD | 2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland | Lublin | Lublin Voivodeship | 20-081 | Poland |
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| neoadjuvant chemotherapy (cisplatin, 5-fluorouracil) | Drug | 21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval |
|
| neoadjuvant chemoradiotherapy | Radiation | 21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 with concurrent external beam fractionated irradiation to a total dose of 30Gy (2Gy fractions on days 1-5, 8-12, 15-19) followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval |
|
| 60-day |
| curative resection rate | 30-day |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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