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

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 - Cisplatin-pemetrexed and stereotactic radiotherapy in stage IB NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32798

Enrollment

Registered

2008-10-14

Start date

2008-12-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

lung cancer lung carcinoma

Interventions

Standard treatment for these patients is stereotactic radiotherapy. Three courses of cisplatin-pemetrexed will be administered before or after radiotherapy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Safety and feasibility of treatment with cisplatin-pemetrexed before or after stereotactic radiotherapy.	—

Secondary

Measure	Time frame
none	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)