Adjuvant Chemotherapy for High Post-operative Recurrence Risk Stage pI Lung Adenocarcinoma

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation are high risk factors of post-operative recurrence for early-stage lung adenocarcinoma patients. The purpose of this clinical trial is to determine whether the widely used adjuvant chemotherapy strategy cisplatin/ pemetrexed is more effective than no further treatment for Stage pI lung adenocarcinoma patients with high post-operative recurrence risk - in terms of no dose related toxicities, premature treatment withdrawal or death.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Pemetrexed

Criteria

Inclusion Criteria:

1. Stage pI lung adenocarcinoma confirmed through formalin-fixed paraffin-embedded tumor tissue, complete resection with mediastinal lymph node dissection

2. Meet one of following conditions: a, Solid predominant adenocarcinomas; b, micropapillary predominant adenocarcinoma; c, low differentiation, unable to identify histological subtypes; d, pleural involvement; e, vascular involvement with solid subtype component or micropapillary component.

3. Aged 18-70 years old.

4. Eastern Cooperative Oncology Group score standard (ECOG) status 0-1.

5. Medical condition permits adjuvant chemotherapy.

6. Patients accept the clinical trial protocol and Informed Consent Form (ICF) signed.

Exclusion Criteria:

1. Concurrent other malignancies

2. Prior chemotherapy and/or radiation therapy for lung cancer

3. Central type lung cancer

4. Concurrent other unresected suspicious nodules or masses in lung

5. Medical condition that will not permit treatment or follow up according to the protocol, or ECOG status >1.

6. Pregnant or nursing women.