Clinical trial · Interventional
Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer
Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)
NCT02568033CI-TRIAL-00025723unknownEarly Phase 1ClinicalTrials.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)
This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Chemotherapy: for Non-Squamous Cell: Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of 21 day cycle or Carboplatin AUC6 and Paclitaxel 75 mg/m2 on day 1 of 21 day cycle for Squamous Cell: Cisplatin 75 mg/m2 and docetaxel 75mg m2 day 1 of 21 day cycle or Carboplatin AUC6 and paclitaxel 200 mg/m2 day 1 of 21 day cycle Radiation- Stereotactic radiosurgery Peripheral Lung lesion: 60 Gy over 3 fractions Central Lung lesion: 50 Gy over 5 fractions Hilar and Mediastinal LNs 40-50Gy over 5 fractions Schedule is: 2 cycles of chemotherapy, followed by SRS, followed by 2 additional cycles of chemotherapy.
- interventionNames
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Docetaxel
- Drug: Paclitaxel
- Radiation: stereotactic radiosurgery
Primary outcomes (2)
- measure
- Disease free progression
- timeFrame
- 4-6 months
- description
- Local control will be evaluated at end of treatment (4-6 months) and then at regular follow up intervals.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Nonsmall cell lung cancer (NSCLC) (any histology) * unresectable stage II * Stage III * Tumor less than 8 cm * Karnofsky performance scale (KPS) of 50 or better * Three or fewer mediastinal or hilar lymph nodes Exclusion criteria * Small cell lung cancer (SCLC) * Stage I and stage IV patients * Stage II patients eligible for surgical resection * Concurrent severe disease that the treating physician feels will interfere with therapy this can include significant cardiovascular or pulmonary disease. * KPS 40 or less (bed bound) * Tumor size greater than 8 cm * Inability to safely treat target lesions (at discretion of treating physician, this would most likely be secondary to not being able to place fiducial markers for tracking) * Four or more medisatinal or hilar lymph nodes
References
Publications (1)
- DERIVEDKubicek GJ, Khrizman P, Squillante C, Callahan K, Xu Q, Abouzgheib W, Boujaoude Z, Patel A, Hageboutros A. Stereotactic Body Radiotherapy and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer: Single Arm Phase 2 Study. Am J Clin Oncol. 2022 Mar 1;45(3):129-133. doi: 10.1097/COC.0000000000000892. PMID 35195562