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

A Randomized Multicenter Phase II Study Of Induction Therapy With Pemetrexed And Cisplatin Followed By Chemoradiation With Pemetrexed Versus Chemoradiation With Pemetrexed Followed By Consolidation Therapy With Pemetrexed And Cisplatin In Patients With Stage III Non-Small Cell Lung Cancer: Paccora Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00497315

Acronym

PACCORA

Enrollment

Registered

2007-07-06

Start date

2006-02-28

Completion date

2009-03-31

Last updated

2009-04-10

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

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, locally advanced NSCLC, pemetrexed, lung cancer

Brief summary

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.

Interventions

DRUGcombination chemotherapy (pemetrexed + cisplatin)

pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)

RADIATIONthoracic irradiation + pemetrexed

pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Response rate	after each treatment modality and 5 year follow-up

Secondary

Measure	Time frame
Toxicity	at the end of each cycle and 5 year follow-up
Time to progression	5 year follow-up
Overall survival	median survival and 2-year survival

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026