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CompletedNCT00497315PACCORAUpdated Apr 10, 2009

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

A Phase 2 interventional study of combination chemotherapy (pemetrexed + cisplatin) and thoracic irradiation + pemetrexed in Non-Small Cell Lung Cancer, sponsored by University Hospital, Antwerp. Completed at 3 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-10.

Sponsored by University Hospital, Antwerp · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Chemoradiation
  • locally advanced NSCLC
  • pemetrexed
  • lung cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 30 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    A

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

    Drug: combination chemotherapy (pemetrexed + cisplatin) · Radiation: thoracic irradiation + pemetrexed

  • Experimental
    B

    thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin

    Drug: combination chemotherapy (pemetrexed + cisplatin) · Radiation: thoracic irradiation + pemetrexed

Interventions

  • Drugcombination chemotherapy (pemetrexed + cisplatin)

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

    Also known as: Alimta

  • Radiationthoracic irradiation + pemetrexed

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

    Also known as: Alimta

06

What researchers measure

Primary outcomes

  1. Response rate

    Time frame: after each treatment modality and 5 year follow-up

Secondary outcomes

  1. Toxicity

    Time frame: at the end of each cycle and 5 year follow-up

  2. Time to progression

    Time frame: 5 year follow-up

  3. Overall survival

    Time frame: median survival and 2-year survival

07

Study locations

3 sites
  • ZNA Middelheim
    Antwerp, Antwerp 2020, Belgium
  • University Hospital Antwerp
    Edegem, Antwerp 2650, Belgium
  • St Augustinus Ziekenhuis
    Wilrijk, Antwerp 2610, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00497315
First posted
Jul 6, 2007
Start date
Feb 2006
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Apr 10, 2009

Study contacts

Paul R Germonpre, MD PhD
principal investigator · Universiteit Antwerpen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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