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JCOG2012: A randomized phase III trial of postoperative surveillance for pathological stage II-IIIA non-small cell lung cancer

JCOG2012: A randomized phase III trial of postoperative surveillance for pathological stage II-IIIA non-small cell lung cancer - PHOENIX

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030220361
Enrollment
1100
Registered
2022-10-05
Start date
2022-10-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Arm A (standard surveillance): (i) physical examination and visual inspection every 6 months for 5 years after surgery, (ii) tumor marker (CEA) test every 6 monthe for 5 years after surgery, (iii) che

Sponsors

SHIONO Satoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Pathologically proven non small cell lung cancer (adenocarcinoma, squamous cell carcinoma, large cell nuroendcrine carcinoma or carcinoid tumours in neuroendocrine tumours, large cell carcinoma, adenosquamous carcinoma, sarcomatoid carcinoma other and unclassified carcinoma or salivary gland-type tumours) with resected specimen (2) Received segmentectomy, lobectomy, or pneumonectomy with mediastinal lymphadenectomy (3) Patholocial stage IIA, IIB or IIIA (4) Pathologically confirmed complete resection (R0) (including R0(un)) with resected specimen (5) Aged 20 years or older at the registration (6) ECOG Performance status is 0 or 1 (7) No complications after surgery which needs treatment (8) No recurrence defined as plain chest X-ray after surgery (9) Within 91 days after surgery (10) No prior and planed radiotherapy for the lung cancer after surgery (11) Written informed consent isobtained

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies 2) Severe psychological disease. 3) Routine thoracoabdominal and pelvic CT scan at least once a year due to past medical history / comorbidities

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
Relapse-free survival, Disease-free survival, Proportion of local reccurence, Proportion of clinical reccurence, Proportion of second malignancies, Number of CT examed, Number of each imaging test (except CT), Proportion of adverse events (adverse reactions), lung cancer-specific survival

Contacts

Public ContactSatoshi SHIONO

Yamagata University Hospital

s-shiono@med.id.yamagata-u.ac.jp+81-23-628-5342

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026