Clinical trial · Interventional
Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combination chemotherapy (pemetrexed + cisplatin) | Drug | — | UNRESOLVED |
| thoracic irradiation + pemetrexed | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed
- interventionNames
- Drug: combination chemotherapy (pemetrexed + cisplatin)
- Radiation: thoracic irradiation + pemetrexed
- type
- EXPERIMENTAL
- label
- B
- description
- thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin
- interventionNames
- Drug: combination chemotherapy (pemetrexed + cisplatin)
- Radiation: thoracic irradiation + pemetrexed
Primary outcomes (1)
- measure
- Response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available