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Ivor-Lewis resection versus left thoracic resection after neoadjuvant chemotherapy for gastroesophageal junction adenocarcinoma (cT1bN+, cT2-T4aN0-N+): A multi-center prospective randomized clinical trial

Ivor-Lewis resection versus left thoracic resection after neoadjuvant chemotherapy for gastroesophageal junction adenocarcinoma (cT1bN+, cT2-T4aN0-N+): A multi-center prospective randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17013113
Enrollment
Unknown
Registered
2017-10-26
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophagogastric junction adenocarcinoma

Interventions

Group A:Ivor-Lewis resection after neoadjuvant chemotherapy
Group B:Left thoracic resection after neoadjuvant chemotherapy

Sponsors

Department of Esophageal Cancer, Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Esophagogastric junction adenocarcinoma with pathologic diagnosis; 2. Siewert I and Siewert II Esophagogastric junction adenocarcinoma; 3. Tumor stage belongs to cT1bN+ or cT2-T4aN0-N+; 4. ECOG more that 0-1. More than 12 months of expected suvival; 5. Absolute white blood cells count >=4.0*10^9/L, neutrophil >=1.5*10^9/L, platelets >=100.0*10^9/L, hemoglobin >=90g/L, and normal functions of liver and kidney; 6. Signed informed consent document on file.;Inclusion criteria: 1. Esophagogastric junction adenocarcinoma with pathologic diagnosis; 2. Siewert I and Siewert II Esophagogastric junction adenocarcinoma; 3. Tumor stage belongs to cT1bN+ or cT2-T4aN0-N+; 4. ECOG more that 0-1. More than 12 months of expected suvival; 5. Absolute white blood cells count >=4.0*10^9/L, neutrophil >=1.5*10^9/L, platelets >=100.0*10^9/L, hemoglobin >=90g/L, and normal functions of liver and kidney; 6. Signed informed consent document on file.;Inclusion criteria: 1. Esophagogastric junction adenocarcinoma with pathologic diagnosis; 2. Siewert I and Siewert II Esophagogastric junction adenocarcinoma; 3. Tumor stage belongs to cT1bN+ or cT2-T4aN0-N+; 4. ECOG more that 0-1. More than 12 months of expected suvival; 5. Absolute white blood cells count >=4.0*10^9/L, neutrophil >=1.5*10^9/L, platelets >=100.0*10^9/L, hemoglobin >=90g/L, and normal functions of liver and kidney; 6. Signed informed consent document on file.;Inclusion criteria: 1. Esophagogastric junction adenocarcinoma with pathologic diagnosis; 2. Siewert I and Siewert II Esophagogastric junction adenocarcinoma; 3. Tumor stage belongs to cT1bN+ or cT2-T4aN0-N+; 4. ECOG more that 0-1. More than 12 months of expected suvival; 5. Absolute white blood cells count >=4.0*10^9/L, neutrophil >=1.5*10^9/L, platelets >=100.0*10^9/L, hemoglobin >=90g/L, and normal functions of liver and kidney; 6. Signed informed consent document on file.;Inclusion criteria: 1. Esophagogastric junction adenocarcinoma with pathologic diagnosis; 2. Siewert I and Siewert II Esophagogastric junction adenocarcinoma; 3. Tumor stage belongs to cT1bN+ or cT2-T4aN0-N+; 4. ECOG more that 0-1. More than 12 months of expected suvival; 5. Absolute white blood cells count >=4.0*10^9/L, neutrophil >=1.5*10^9/L, platelets >=100.0*10^9/L, hemoglobin >=90g/L, and normal functions of liver and kidney; 6. Signed informed consent document on file.

Exclusion criteria

Exclusion criteria: 1. Patients with prior treatment for esophageal cancer; 2. With a prior malignancy tumor; 3. Can not sign informed consent document on file for psychological, familial and societal factors.;Exclusion criteria: 1. Patients with prior treatment for esophageal cancer; 2. With a prior malignancy tumor; 3. Can not sign informed consent document on file for psychological, familial and societal factors.;Exclusion criteria: 1. Patients with prior treatment for esophageal cancer; 2. With a prior malignancy tumor; 3. Can not sign informed consent document on file for psychological, familial and societal factors.;Exclusion criteria: 1. Patients with prior treatment for esophageal cancer; 2. With a prior malignancy tumor; 3. Can not sign informed consent document on file for psychological, familial and societal factors.;Exclusion criteria: 1. Patients with prior treatment for esophageal cancer; 2. With a prior malignancy tumor; 3. Can not sign informed consent document on file for psychological, familial and societal factors.

Design outcomes

Primary

MeasureTime frame
3-year overall survival;

Secondary

MeasureTime frame
progression-free survival;Recurrence-free survival;pathological response rate;R0 resection rate;lymph node dissection;postoperative major complications;

Countries

China

Contacts

Public ContactZhentao Yu;Zhentao Yu;Zhentao Yu;Zhentao Yu;Zhentao Yu ;;;;

Tianjin Medical University Cancer Institute and Hospital;Tianjin Medical University Cancer Institute and Hospital;Tianjin Medical University Cancer Institute and Hospital;Tianjin Medical University Cancer Institute and Hospital;Tianjin Medical University Cancer Institute and Hospital

yuzhtao@hotmail.com;yuzhtao@hotmail.com;yuzhtao@hotmail.com;yuzhtao@hotmail.com;yuzhtao@hotmail.com+86 18622221066;+86 18622221066;+86 18622221066;+86 18622221066;+86 18622221066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026