Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
Recruiting now · Phase 3
Conditions studied: Locally Advanced Gastric Cancer
In brief
In this study the patients with histological evidence of adenocarcinoma of the stomach will be screened and, if eligible, submitted to neo-adjuvant chemotherapy (NAC). After conclusions of NAC and obtaining informed consent, they will be registered and randomized to receive surgical D2 vs. D2plus lymphadenectomy.
Key facts
- Study ID
- NCT03961373
- Run by
- University of Siena
- People needed
- 539
- Starts
- 2018-11-05
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2019-05-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age equal or greater than 18 years
- IIA-IIIC histologically proven primary gastric adenocarcinoma, before the treatment with NAC. Not including gastro-oesophageal junction/cardia carcinoma but only Siewert 3, without any previous treatment (surgery and / or chemotherapy) for this diagnosis
- Lack in CT scan of following:
- Mediastinal lymph nodes
- Lung metastases
- Peritoneal metastases
- Liver metastases
- Pleural effusion, ascites
- Metastases to para-aortic lymph nodes No 16a2/b1
- Metastases to lymph nodes located in the "posterior" area (8p, 12 b/p, 13)
- Extra-regional lymph node metastases
- ECOG performance status ≤ 2
- No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
- No oesophageal invasion, or invasion <=3cm
- Negative peritoneal washing cytology findings and no peritoneal metastases in staging laparoscopy
- No gastric stump cancer
- No signs of cervical and subclavear lymph nodes or distal metastases
- Patient's consent form obtained, signed and dated before beginning specific protocol procedures
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
You may not qualify if…
- Contraindications for any sort of appropriate chemotherapy according to local standards
- Linitis plastica
- Second uncontrolled malignant tumour (synchronous or metachronous (last 5 years) other than Cis or mucosal cancer
- Neoplasms involving the esophago-gastric junction (Siewert types I and II)
- Expected unresectability after neo-adjuvant treatment or progression in metastases
- Emergency surgery due to bleeding or perforation
- Uncontrolled infections
- Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
- Pregnant or lactating women
- Significant neurologic or psychiatric disorders
- Severe cardiac illness (NYHA class IV)
- Under treatment of systemic steroids
- Participation in any other clinical trial that might interfere with the results of this trial
- Lack of compliance
- Inability to fill in questionnaires (insufficient command of language, dementia, lack of time)
Where it is running
- General and Surgical Oncology Department, University of Siena — Siena, Italy (enrolling)
Full record on ClinicalTrials.gov
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