Non-Small Cell Lung CancerPhase 2PACCORANCT00497315
Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing combination chemotherapy (pemetrexed + cisplatin) and thoracic irradiation + pemetrexed in people with Non-Small Cell Lung Cancer, run by University Hospital, Antwerp at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- combination chemotherapy (pemetrexed + cisplatin) and thoracic irradiation + pemetrexed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesBelgium
- Study dates
- Feb 2006to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
ZNA Middelheim
Antwerp, Antwerp, 2020
University Hospital Antwerp
Edegem, Antwerp, 2650
St Augustinus Ziekenhuis
Wilrijk, Antwerp, 2610
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- combination chemotherapy (pemetrexed + cisplatin), thoracic irradiation + pemetrexed
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, locally advanced NSCLC, pemetrexed, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination chemotherapy (pemetrexed + cisplatin)Drug
Also called Alimta
pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
thoracic irradiation + pemetrexedRadiation
Also called Alimta
pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed Receives: Drug: combination chemotherapy (pemetrexed + cisplatin); Radiation: thoracic irradiation + pemetrexed |
| B | Experimental | thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin Receives: Drug: combination chemotherapy (pemetrexed + cisplatin); Radiation: thoracic irradiation + pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: after each treatment modality and 5 year follow-up
Secondary outcomes (3)
Toxicity
Measured: at the end of each cycle and 5 year follow-up
Time to progression
Measured: 5 year follow-up
Overall survival
Measured: median survival and 2-year survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startFeb 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, Eli Lilly and Company
- Investigators
- Paul R Germonpre, MD PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497315
- Sponsor's protocol ID
- TOGA 0502
- Other IDs
- Eudra CT 2005-004030-40
- Acronym
- PACCORA
- Status last verified
- Apr 2009
- First submitted
- 4 Jul 2007
- Last updated
- 10 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00497315
- Acronym / sponsor ID
- PACCORA / TOGA 0502
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, locally advanced NSCLC, pemetrexed, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, Eli Lilly and Company
- Study start
- Feb 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: combination chemotherapy (pemetrexed + cisplatin), Radiation: thoracic irradiation + pemetrexedpemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed |
| B | Experimental | Drug: combination chemotherapy (pemetrexed + cisplatin), Radiation: thoracic irradiation + pemetrexedthoracic irradiation + pemetrexed followed by pemetrexed + cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination chemotherapy (pemetrexed + cisplatin)Also: Alimtapemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles) | Drug | A, B |
| thoracic irradiation + pemetrexedAlso: Alimtapemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY) | Radiation | A, B |
Primary outcome
Response rate
Time frame: after each treatment modality and 5 year follow-up
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul R Germonpre, MD PhD principal investigator
Universiteit Antwerpen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing combination chemotherapy (pemetrexed + cisplatin) and thoracic irradiation + pemetrexed in people with Non-Small Cell Lung Cancer, run by University Hospital, Antwerp at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: after each treatment modality and 5 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2009.