Clinical trial · Interventional
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
- 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)
Primary objectives of the study are: To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively Secondary objectives are: To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Chemotherapy and radiotherapy | Other | — | UNRESOLVED |
| Palliative radiotherapy and chemotherapy | Other | — | UNRESOLVED |
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy
- description
- For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
- interventionNames
- Radiation: radiation
- type
- EXPERIMENTAL
- label
- Chemotherapy and radiotherapy
- description
- For patients in Group A (either stage IIIA or IIIB) receive a course of up to 3 cycles of chemotherapy followed by EBRT of 10 Gy in a single fraction or 16 Gy in 2 fractions 1 week apart.
- interventionNames
- Other: Chemotherapy and radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Study A Inclusion Criteria: * Histologically or cytologically confirmed NSCLC * Stage IIIA/IIIB staged with * CT chest and upper abdomen * Liver, renal, hematological reserve appropriate (according to "standard" institutional values) * Brain CT and/or bone scan only if clinical symptoms request such investigation * Performance status KPS 60-90 * No second cancer except skin non-melanoma * No previous treatment * Patient must be contactable for follow-up * Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed) * Life expectancy \> 3 months * Patient must be able and willing to give informed consent, and fill in questionnaires Study A Exclusion Criteria: * Stage III B "wet" (existing pleural effusion , but not necessarily cytologically verified) * RT field \> 200 cm2 * Pregnancy Study B Inclusion Criteria: * KPS 60-90 * Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified) * Histologically or cytologically confirmed * CT staged disease (thorax and possible upper abdomen) * No second cancer except skin non-melanoma * Liver, renal, haematological reserve appropriate (according to "standard" institutional values) * No previous treatment * Patient must be contactable for follow-up * Patient must be able and willing to give informed consent and fill in questionnaires * Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed) * Life expectancy \> 3 months Study B Exclusion Criteria: * Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated) * RT field \> 200 cm2 * Pregnancy * A-P separation too large to be adequately treated with 60-Co (?)
References
Publications (1)
- DERIVEDJeremic B, Fidarova E, Sharma V, Faheem M, Ameira AA, Nasr Ben Ammar C, Frobe A, Lau F, Brincat S, Jones G. The International Atomic Energy Agency (IAEA) randomized trial of palliative treatment of incurable locally advanced non small cell lung cancer (NSCLC) using radiotherapy (RT) and chemotherapy (CHT) in limited resource setting. Radiother Oncol. 2015 Jul;116(1):21-6. doi: 10.1016/j.radonc.2015.06.017. Epub 2015 Jul 7. PMID 26163093