A 2-step phase I study evaluating the safety of (neo-)adjuvant cisplatin-pemetrexed and stereotactic radiotherapy for patients with stage IB non-small-cell lung cancer

• Conditions: lung cancer; lung carcinoma; 10038666

• Registration Number: NL-OMON32798
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Any histologically or cytologically proven NSCLC
2. Stage IB NSCLC (T2N0M0)
3. FDG-PET scan consistent with stage IB NSCLC
4. Age 18 years or older
5. Patients should be fit to undergo chemotherapy and be eligible for SRT
using 5 or 8 fractions as specified
6. Adequate organ function
7. signed informed consent
8. male and female patients with reproductive potential must use an
approved contraceptive method, if appropriate. Female patients with
childbearing potential must have a negative serum pregnancy test within
7 days prior to study enrollment.

Exclusion Criteria

1. Pregnant or lactating women
2. Concomitant treatment with any other experimental drug under
investigation.
3. Inability or unwillingness to take folic acid or vitamin B-12
supplementation
4. Diagnosis of a synchronous second malignancy
5. Small-Cell Lung cancer (SCLC) or a mixed SCLC-NSCLC
6. Prior thoracic radiotherapy
7. Prior systemic anti-cancer chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and feasibility of treatment with cisplatin-pemetrexed before or after<br /><br>stereotactic radiotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>none</p><br>