Clinical trial · Interventional
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer
Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Stage III Non-small Cell Lung Cancer
NCT03099577CI-TRIAL-00038439completedN/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 goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin \& paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiochemotherapy 1 | Radiation | — | UNRESOLVED |
| radiochemotherapy 2 | Radiation | — | UNRESOLVED |
| radiochemotherapy 3 | Radiation | — | UNRESOLVED |
| radiochemotherapy 4 | Radiation | — | UNRESOLVED |
| radiochemotherapy 5 | Radiation | — | UNRESOLVED |
| radiochemotherapy 6 | Radiation | — | UNRESOLVED |
| radiochemotherapy 7 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- radiochemotherapy 1
- description
- Patients will be treated with radiation therapy 64.8 Gy
- interventionNames
- Radiation: radiochemotherapy 1
- type
- EXPERIMENTAL
- label
- radiochemotherapy 2
- description
- Patients will be treated with radiation therapy 69.6 Gy
- interventionNames
- Radiation: radiochemotherapy 2
- type
- EXPERIMENTAL
- label
- radiochemotherapy 3
- description
- Patients will be treated with radiation therapy 74.4 Gy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer. 2. Age 1 8-75. 3. Zubrod performance status 0-2. 4. Stage III ( American Joint Committee on Cancer AJCC, 7th ed.). 5. No prior radiation to the thorax that would overlap with the current treatment field. 6. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</=1 .5 times ULN. 7. A signed informed consent must be obtained prior to therapy. 8. Induction chemotherapy is allowed. 9. Life expectancy more than 3 months. Exclusion Criteria: 1. Patients with any component of small cell lung carcinoma are excluded from this study. 2. Patients with evidence of a malignant pleural or pericardial effusion are excluded. 3. Prior radiotherapy that would overlap the radiation fields. 4. Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. 5. Known hypersensitivity to paclitaxel. 6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. 7. Acquired Immune Deficiency Syndrome. 8. Conditions precluding medical follow-up and protocol compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.