Clinical trial · Interventional
Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy
Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
NCT01664663CI-TRIAL-00016304PLANETterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Safety analysis showed increased grade 5 toxicity in experimental arm.
Summary
Brief summary (as posted)
The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Disease | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose escalated radiochemotherapy up to 84 Gy | Radiation | — | UNRESOLVED |
| Standard radiochemotherapy to 68 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A:Standard radiochemotherapy
- description
- Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation.
- interventionNames
- Radiation: Standard radiochemotherapy to 68 Gy
- type
- EXPERIMENTAL
- label
- Arm B Escalated radiochemotherapy
- description
- Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation.
- interventionNames
- Radiation: Dose escalated radiochemotherapy up to 84 Gy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of NSCLC stage IIIA-B. * Nonresectable or medically inoperable patients. * No prior chemo- or radiotherapy for NSCLC. * PS 0-1. * FEV1 \> 1 l or \> 40% and CO diffusion capacity \> 40%. * Patient compliance and geographic proximity that allow adequate follow-up. * Adequate bone marrow reserve: WBCC \>3.0, platelets \>100, haemoglobin \> 100. * Written informed concent. * Effective use of contraception. Exclusion Criteria: * Excessive weight loss within 6 months (\> 10%). * Supraclavicular nodes. * Apical tumors-pancoast. * T4 tumors with separate manifestations in different lobes. * Evidence of active serious infections. * Inadequate liver function. * Inadequate kidney function. * Pregnancy. * Breast feeding. * Serious concomitant systemic disorder. * Second primary malignancy the last 5 years.
References
Publications (1)
- DERIVEDHallqvist A, Bergstrom S, Bjorkestrand H, Svard AM, Ekman S, Lundin E, Holmberg E, Johansson M, Friesland S, Nyman J. Dose escalation to 84 Gy with concurrent chemotherapy in stage III NSCLC appears excessively toxic: Results from a prematurely terminated randomized phase II trial. Lung Cancer. 2018 Aug;122:180-186. doi: 10.1016/j.lungcan.2018.06.020. Epub 2018 Jun 18. PMID 30032828