Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery

Phase 2

• Conditions: non-small cell lung cancer

• Registration Number: JPRN-jRCTs051180052
• Lead Sponsor: Shintani Yasushi

Brief Summary

The effects of ANP for preventing postoperative recurrence following lung cancer surgery were not confirmed. Fabrication or falsification was found in the reference paper used for planning the study, thus its scientific validity has been lost. Therefore, these results do not provide justification for further clinical trials for cancer treatment using ANP and a new observational study is required to investigate the relationship between postoperative adverse events and ANP administration be reexamined.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-08
• Study Completion: 2020-12-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

1. Non-small cell lung cancer is suspected.
2. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is more than 0.25.
3. It's possible to perform the complete resection.
4. Lymph node dissection more than ND2a or selective lymph node dissection
5. Patient without simultaneous or metachronous (within the past 5 years) double cancers.
6. Aged more than 20 years
7. Performance status of 0-2.
8. Sufficient organ function matching following criteria,
neutrophil count: more than 1500 /uL
platelet count: more than 100000 /uL
hemoglobin: more than 8.0 g/dL
AST and ALT: less than 100 IU/L
total bilirubin: less than 1.5mg/dL
SpO2 (under room air): more than 92%
9. All patients gave written informed consent

Exclusion Criteria

1. Patient with active the other concurrent malignant diseases.
2. Women during pregnancy or breast-feeding.
3. Psychosis.
4. Systemic steroids or immunosuppressive agents medication.
5. Uncontrollable infectious disease
6. Uncontrollable severe comorbidities.
7. Uncontrollable autoimmune disease
8. History of right ventricular infarction.
9. Severe hypotension
10. Dehydration that continues though patient receives treatments.
11. Other conditions judged ineligible by physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS)

Secondary Outcome Measures

Name	Time	Method
1. Five-year relapse free survival after lung cancer surgery <br>2. Over all survival (5 years after surgery) <br>3. The ratio of the patients who completed the treatment <br>4. The incidence of postoperative complications