Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (PACCORA)

Antwerp University Hospital (UZA)

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: combination chemotherapy (pemetrexed + cisplatin)

Radiation: thoracic irradiation + pemetrexed

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00497315

Eudra CT 2005-004030-40

TOGA 0502

Details and patient eligibility

About

The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

cytological or histological proven NSCLC
unresectable stage III NSCLC
presence of at least one measurable lesion (RECIST criteria)
adequate haematological, renal and hepatic function
adequate lung function reserve
good condition, weight loss <10 % over previous 6 months, life expectancy > 3 months

Exclusion criteria

previous chemo- or radiotherapy for NSCLC
distant metastasis or a malignant pleural or pericardial effusion
second active primary malignancy or serious concomitant medical disease
interstitial lung disease
auto-immune systemic disease with potential involvement of the lungs
inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period
concomitant use of amiodarone