NCT03961373 Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
| NCT ID | NCT03961373 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Siena |
| Condition | Locally Advanced Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 539 participants |
| Start Date | 2018-11-05 |
| Primary Completion | 2023-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 539 participants in total. It began in 2018-11-05 with a primary completion date of 2023-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. Mediastinal lymph nodes 2. Lung metastases 3. Peritoneal metastases 4. Liver metastases 5. Pleural effusion, ascites 6. Metastases to para-aortic lymph nodes No 16a2/b1 7. Metastases to lymph nodes located in the "posterior" area (8p, 12 b/p, 13) 8. 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 Exclusion Criteria: * 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)
Contact & Investigator
Franco Roviello
PRINCIPAL INVESTIGATOR
University of Siena
Frequently Asked Questions
Who can join the NCT03961373 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Locally Advanced Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03961373 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 539 participants.
Is NCT03961373 currently recruiting?
Yes, NCT03961373 is actively recruiting participants. Contact the research team at daniele.marrelli@unisi.it for enrollment information.
Where is the NCT03961373 trial being conducted?
This trial is being conducted at Siena, Italy.
Who is sponsoring the NCT03961373 clinical trial?
NCT03961373 is sponsored by University of Siena. The principal investigator is Franco Roviello at University of Siena. The trial plans to enroll 539 participants.
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