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

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: combination chemotherapy (pemetrexed + cisplatin) Radiation: thoracic irradiation + pemetrexed	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:

Response rate [ Time Frame: after each treatment modality and 5 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Time Frame: at the end of each cycle and 5 year follow-up ] [ Designated as safety issue: Yes ]
Time to progression [ Time Frame: 5 year follow-up ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: median survival and 2-year survival ] [ Designated as safety issue: No ]


Enrollment:	30
Study Start Date:	February 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497315

Locations


Belgium
ZNA Middelheim
Antwerpen, Antwerp, Belgium, 2020
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
St Augustinus Ziekenhuis
Wilrijk, Antwerp, Belgium, 2610

Sponsors and Collaborators

University Hospital, Antwerp

Thoracic Oncology Group Antwerp

Eli Lilly and Company

Investigators


Principal Investigator:	Paul R Germonpre, MD PhD	Thoracic Oncology Group Antwerp

More Information

No publications provided


Responsible Party:	Thoracic Oncology Group Antwerp - Paul Germonpre, Thoracic Oncology Group Antwerp
ClinicalTrials.gov Identifier:	NCT00497315 History of Changes
Other Study ID Numbers:	TOGA 0502, Eudra CT 2005-004030-40
Study First Received:	July 4, 2007
Last Updated:	April 9, 2009
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by University Hospital, Antwerp:


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

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Cisplatin	Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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