Actively Recruiting
Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
Led by University of Siena · Updated on 2019-05-23
539
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical approaches after neo-adjuvant chemotherapy in patients with locally advanced adenocarcinoma of the stomach without distant metastases. The study aims to compare standard D2 lymphadenectomy with super-extended D2plus lymphadenectomy to see which provides better overall and cancer-related survival. This phase III trial involves patients with specific lymph node involvement and no previous treatments for this cancer. Participants will receive neo-adjuvant chemotherapy followed by either subtotal or total gastrectomy depending on tumor location. One group will undergo standard D2 lymph node dissection, while the experimental group will receive a more extensive lymphadenectomy including additional stations. Surgery is scheduled 4 to 6 weeks after completing chemotherapy. The trial compares these two surgical techniques during the same treatment timeline. During the study, researchers will assess overall survival about 5 years after diagnosis, along with recurrence-free survival, postoperative complications, and mortality within 30 days or hospital stay. They will also evaluate the surgery's completeness, chemotherapy response, quality of life, and hospitalization duration. Participants' progress will be followed closely with planned assessments over several years to monitor outcomes and safety.
CONDITIONS
Brief Title
Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age equal or greater than 18 years
- Histologically confirmed stage IIA to IIIC primary gastric adenocarcinoma before neo-adjuvant chemotherapy
- No previous treatment (surgery or chemotherapy) for this diagnosis
- No evidence of mediastinal lymph nodes, lung, peritoneal, liver metastases, pleural effusion, ascites, or metastases to para-aortic or extra-regional lymph nodes
- ECOG performance status of 2 or less
- No oesophageal invasion greater than 3 cm
- Negative peritoneal washing cytology and no peritoneal metastases by staging laparoscopy
- No gastric stump cancer
- No signs of cervical or subclavicular lymph node involvement or distant metastases
- Signed informed consent
- No psychological, familial, sociological, or geographical conditions preventing study compliance
You will not qualify if you...
- Contraindications to chemotherapy
- Linitis plastica
- Second uncontrolled malignant tumor in the last 5 years except certain skin cancers
- Esophago-gastric junction tumors of Siewert types I and II
- Expected unresectability or progression to metastases after chemotherapy
- Emergency surgery due to bleeding or perforation
- Uncontrolled infections
- Serious underlying medical conditions affecting participation
- Pregnant or breastfeeding women
- Significant neurologic or psychiatric disorders
- Severe cardiac illness (NYHA class IV)
- Under systemic steroid treatment
- Participation in another interfering clinical trial
- Lack of compliance
- Inability to complete questionnaires due to language, dementia, or time constraints
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of chemotherapy cycles as per protocol (not specified)
Participants receive chemotherapy before surgery to shrink the tumor.
Multiple visits for chemotherapy administration (cadence not specified)
Duration - Surgical treatment performed within 4 to 6 weeks after chemotherapy completion
Participants undergo either subtotal or total gastrectomy with lymphadenectomy, either standard D2 or extended D2plus, depending on randomization.
1 surgical hospitalization
Duration - Approximately 3 months after surgery
Participants are monitored for surgical complications and recovery after the operation.
Follow-up visits within 30 days and up to 3 months post-operation
Duration - Up to 5 years after diagnosis
Participants are followed for overall survival, recurrence, and quality of life up to approximately 5 years after diagnosis.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
General and Surgical Oncology Department, University of Siena
Siena, Italy, 53100
Actively Recruiting
Research Team
D
Daniele Marrelli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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