Clinical trial · Interventional
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
A Randomized, Phase III, Open-Label Study of Oral Topotecan Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
- 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 current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.
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, Non-Small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HYCAMTIN, oral capsules | Drug | Topotecan | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- topotecan plus radiation
- description
- topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy.
- interventionNames
- Drug: HYCAMTIN, oral capsules
- Radiation: Radiation
- type
- ACTIVE_COMPARATOR
- label
- Whole brain radiation
- description
- Whole brain radiation 3 Gy/day for 10 days
- interventionNames
- Radiation: Radiation
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC) * Must have received previous chemotherapy * Must be 18 years of age of greater * Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2 * At least 2 weeks must have elapsed since any surgery * At least 4 weeks must have elapsed since any radiation to a non-CNS site * Must have adequate bone marrow, renal, and live capacities * Women must be of non-childbearing potential or practice adequate birth control * Males must practice adequate methods of birth control * Must sign written informed consent Exclusion criteria: * Previous whole brain radiation therapy * Prior treatment with topotecan * Investigational agent within 30 days or 5 half-live * Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib * Primary or secondary immunodeficiencies * Gastrointestinal conditions that affect GI absorption or motility * Uncontrolled emesis * Brain metastasis at time of initial diagnosis of NSCLC * History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer * Pregnant or intending to become pregnant or intending to father a baby * Any severe concurrent medical condition that could affect compliance.
References
Publications (0)
Data not yet available