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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed

Group Type EXPERIMENTAL

combination chemotherapy (pemetrexed + cisplatin)

Intervention Type DRUG

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

thoracic irradiation + pemetrexed

Intervention Type RADIATION

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

B

thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin

Group Type EXPERIMENTAL

combination chemotherapy (pemetrexed + cisplatin)

Intervention Type DRUG

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

thoracic irradiation + pemetrexed

Intervention Type RADIATION

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

Interventions

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combination chemotherapy (pemetrexed + cisplatin)

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

Intervention Type DRUG

thoracic irradiation + pemetrexed

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

Intervention Type RADIATION

Other Intervention Names

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Alimta Alimta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No