Clinical trial · Interventional
Early Hippocampal Avoidance Prophylactic Cranial Irradiation in Patients With LD SCLC
Early Prophylactic Cranial Irradiation With Hippocampal Avoidance in Patients With Limited Disease Small-cell Lung Cancer. A Multicenter Phase II Trial
NCT02058056CI-TRIAL-00043073completedN/AClinicalTrials.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)
The main objective of this trial is to assess NCF after early HA-PCI concomitant to the second cycle of CHT and to tRT for patients with LD SCLC.
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 |
|---|---|---|---|
| Small-Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irradiation: HA-PCI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: HA-PCI treatment
- description
- Irradiation HA-PCI concomitant to the second cycle of CHT and to tRT for patients with LD SCLC
- interventionNames
- Radiation: Irradiation: HA-PCI
Primary outcomes (1)
- measure
- Neurocognitive functioning (NCF)
- timeFrame
- at 6 months
- description
- NCF at 6 months after end of HA-PCI treatment measured by Hopkins Verbal Learning Test Revised (HVLT-R), Controlled Oral Word Association (COWAT) and Trail Making Test Part A and B (TMT A/B). A neurocognitive decline is defined as a decrease of one standard error of measurement (SEM) in any of the four NCF tests.
Secondary outcomes (6)
- measure
- Brain metastasis free survival (BMFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed cytologically or histologically confirmed diagnosis of SCLC within 6 weeks before registration. * Proven LD SCLC (CT thorax, abdomen, and bone scan (or PET/CT only) and brain MRI within 6 weeks before registration) according to the TNM classification version 7 that can be encompassed within a radical radiation port * Only patients assessed by an interdisciplinary tumor board should be declared eligible taking into account eligibility for curative tRT and CHT according to NCCN Guidelines version 2.2014 * Karnofsky Index ≥ 60% * Age at registration 18 to 75 years * Normal bone marrow function: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L * Calculated creatinine clearance ≥ 60 mL/min is required if chemotherapy with cisplatin is scheduled. If cisplatin has to be replaced by carboplatin a creatinine clearance ≥ 50 mL/min is required * Normal liver function: bilirubin ≤ 1 x ULN, AST and ALT ≤1.5 x ULN * Fluency in either German, French or Italian * Women are not breastfeeding. Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 6 months thereafter. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and during 6 months thereafter. * Baseline QoL questionnaires FACT-Br and GHQ-12 have been completed within 14 days before registration * Baseline NCF assessments have been completed within 14 days before registration: * HVLT-R * COWAT * TMT A * TMT B * Patient must give written informed consent before registration Exclusion Criteria: * Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer * History of CNS metastases * Prior brain RT * History of RT to the thorax * Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms, participating in assessing NCF testing or interfering with compliance for oral drug intake. * Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry. * Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes). * Any concomitant drugs contraindicated for use with the treatment drugs according to the approved product information. * History of cerebrovascular disease or epilepsy requiring continuous treatment * Symptomatic cardiac disease or a history of myocardial infarction within the previous 3 months * Any psychological, familial or sociological/geographical conditions potentially hampering compliance with the study protocol and follow-up schedule * Legal incapacity or limited legal capacity
References
Publications (0)
Data not yet available
No reference posted for this study.