Clinical trial · Interventional
Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
NCT00057746CI-TRIAL-00022374completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy. PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic cranial irradiation, 1.5 Gy fx | Radiation | — | UNRESOLVED |
| Prophylactic cranial irradiation, 2.0 Gy fx | Radiation | — | UNRESOLVED |
| Prophylactic cranial irradiation, 2.5 Gy fx | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Prophylactic cranial irradiation, 2.5 Gy fx
- interventionNames
- Radiation: Prophylactic cranial irradiation, 2.5 Gy fx
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Prophylactic cranial irradiation, 2.0 Gy fx
- interventionNames
- Radiation: Prophylactic cranial irradiation, 2.0 Gy fx
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Prophylactic cranial irradiation, 1.5 Gy fx
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
* Limited stage (I-IIIB)
* Confined to 1 hemithorax
* No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
* Complete response after induction chemotherapy (with or without thoracic radiotherapy)
* Consolidative chest radiotherapy may be initiated before study
* No radiographic evidence of any of the following:
* Brain metastases
* Normal brain CT scan or MRI less than 1 month before study
* Ipsilateral lung metastases
* Malignant pleural effusion
* Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 10.0 g/dL\^
Hepatic
* Not specified
Renal
* Not specified
Pulmonary
* See Disease Characteristics
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Neurological function class 1 or 2
* No epilepsy requiring permanent oral medication
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 1 week since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
* Concurrent thoracic radiotherapy allowed
Surgery
* Not specified
Other
* No concurrent antitumor agentsReferences
Publications (4)
- BACKGROUNDGondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.
- BACKGROUNDLe Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20. PMID 19386548
- BACKGROUNDPechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.
- RESULTWolfson AH, Bae K, Komaki R, Meyers C, Movsas B, Le Pechoux C, Werner-Wasik M, Videtic GM, Garces YI, Choy H. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):77-84. doi: 10.1016/j.ijrobp.2010.05.013. Epub 2010 Aug 26. PMID 20800380