Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (PACCORA)
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ClinicalTrials.gov Identifier: NCT00497315 |
Recruitment Status :
Completed
First Posted : July 6, 2007
Last Update Posted : April 10, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: combination chemotherapy (pemetrexed + cisplatin) Radiation: thoracic irradiation + pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: A
pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed
|
Drug: combination chemotherapy (pemetrexed + cisplatin)
pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
Other Name: Alimta Radiation: thoracic irradiation + pemetrexed pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)
Other Name: Alimta |
Experimental: B
thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin
|
Drug: combination chemotherapy (pemetrexed + cisplatin)
pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
Other Name: Alimta Radiation: thoracic irradiation + pemetrexed pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)
Other Name: Alimta |
- Response rate [ Time Frame: after each treatment modality and 5 year follow-up ]
- Toxicity [ Time Frame: at the end of each cycle and 5 year follow-up ]
- Time to progression [ Time Frame: 5 year follow-up ]
- Overall survival [ Time Frame: median survival and 2-year survival ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497315
Belgium | |
ZNA Middelheim | |
Antwerpen, Antwerp, Belgium, 2020 | |
University Hospital Antwerp | |
Edegem, Antwerp, Belgium, 2650 | |
St Augustinus Ziekenhuis | |
Wilrijk, Antwerp, Belgium, 2610 |
Principal Investigator: | Paul R Germonpre, MD PhD | Universiteit Antwerpen |
Responsible Party: | Thoracic Oncology Group Antwerp - Paul Germonpre, Thoracic Oncology Group Antwerp |
ClinicalTrials.gov Identifier: | NCT00497315 |
Other Study ID Numbers: |
TOGA 0502 Eudra CT 2005-004030-40 |
First Posted: | July 6, 2007 Key Record Dates |
Last Update Posted: | April 10, 2009 |
Last Verified: | April 2009 |
Non-Small Cell Lung Cancer NSCLC Chemoradiation |
locally advanced NSCLC pemetrexed lung cancer |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |