Clinical trial · Interventional
Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC
A Phase I Dose Intensification Study Using Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Patients With Inoperable, Non-Small Cell Lung Cancer
NCT00692380CI-TRIAL-00021983terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient accrual
Summary
Brief summary (as posted)
Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractionated radiation therapy followed by chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Fractionated Radiation Therapy followed by Carboplatin and Taxol
- interventionNames
- Radiation: Fractionated radiation therapy followed by chemotherapy
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- To identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D. To estimate complete response rate as defined by PET performed 3 months after completion of all therapy.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically-proven, by biopsy or cytology, unresectable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma, not otherwise specified. * Patient with AJCC Stage IIIA-IIIB, if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes. * 18-fluoro-2-deoxyglucose positron emission tomography required for staging and image fusion for treatment planning. * Atelectasis, if present, must be less than one lung. * Patients must have granulocytes \>1500/µl; platelets \>100,000/µl; bilirubin \< 1.5 mg/dl; AST(SGOT) \< 2 ULN; serum creatinine \< 2.0 mg/dl. * Zubrod Score 0-1. * FEV1 must be \>1.0 L. * Patients must sign a study-specific informed consent form prior to study entry * Patients must have measurable disease on the planning CT. * Patient must have a completed the IMRT plan and the attending physician must have reviewed and approved the dose volume histograms as follows (based on treatment planning to the Phase 4 dose level): total lung V20 \< 30%, mean esophageal dose \< 34 Gy, the esophageal V55 \< 30%, the heart V40 \< 50%. * No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more; no prior lung cancer within last two years. * No prior RT to thorax. * No previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years. * No distant metastases or supraclavicular lymph node involvement or significant atelectasis. * No clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome. Exclusion Criteria: * Undifferentiated small cell (oat cell or high grade neuroendocrine) carcinoma, any stage. * Stage I, II or IV NSCLC. * Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery. * Concurrent malignancy except non-melanomatous skin cancer or prior cancer unless disease-free for one year or more. * Prior radiation therapy to the thorax. * Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years. * Distant metastases or supraclavicular lymph node involvement, or atelectasis of an entire lung. * Patients who have not had the pre-treatment evaluations in Section 4.0 or evaluations performed \> 8 weeks prior to study entry. * Patients with clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome. * Prior lung cancer within the last two years. * Patients who have significant atelectasis and in whom the CT definition of the gross tumor volume(GTV) is difficult to determine. * Pregnant or lactating females. It is not known what effects this treatment may have on the developing fetus.
References
Publications (0)
Data not yet available
No reference posted for this study.