NCT03961373RecruitingPhase 3
Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
Source: ClinicalTrials.gov · Last updated 23 May 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 539 (estimated)
- First submitted
- 12 Mar 2019
- Start date
- 5 Nov 2018
- Primary completion date
- 1 Nov 2023
- Lead sponsor
- University of Siena
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03961373
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 539
- From 5 Nov 2018 to the primary completion date, 1 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications for any sort of appropriate chemotherapy according to local standards
- Under treatment of systemic steroids
Other illness
- Second uncontrolled malignant tumour (synchronous or metachronous (last 5 years) other than Cis or mucosal cancer
- 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
- Significant neurologic or psychiatric disorders
- Severe cardiac illness (NYHA class IV)
- Inability to fill in questionnaires (insufficient command of language, dementia, lack of time)
Other
- Linitis plastica
- Neoplasms involving the esophago-gastric junction (Siewert types I and II)
- Expected unresectability after neo-adjuvant treatment or progression in metastases
- Pregnant or lactating women
- Participation in any other clinical trial that might interfere with the results of this trial
- Lack of compliance
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General and Surgical Oncology Department, University of Siena Coordinator of this site? Confirm its status | Siena | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.