Phase 2
N=63
Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00023673 ↗Enrolled (actual)
63
Serious AEs
70.5%
Results posted
Mar 2014
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy — 0; 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); paclitaxel (Drug); three-dimensional conformal radiation therapy (Radiation)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy |
0; 1 | — |
| PRIMARY Percentage of Patients Who Survive at Least 12 Months |
75.5 | — |
| SECONDARY Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities. |
4; 16; 28; 2; 2; 1 | — |
| SECONDARY Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level) |
24.1; 26.3; 22.4; 26.3 | 0.62 |
| SECONDARY Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level) |
15.2; 17.2; 14.5; 16.9; 21.0; 24.6 | 0.30 |
| SECONDARY Number of Patients With Complete Response at 3 Months After Completion of Therapy |
3 | — |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed unresectable stage IIIB non-small cell lung cancer
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Non-small cell carcinoma not otherwise specified
- All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields
- Measurable disease on 3-dimensional planning CT scan
- No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma
- No stage IV or recurrent disease
- No distant metastases or supraclavicular lymph node involvement
- No significant atelectasis (i.e., atelectasis of an entire lung)
- No pleural effusions, pericardial effusions, or superior vena cava syndrome
- No lung cancer within the past 2 years
- Ineligible for currently open Radiation Therapy Oncology Group (RTOG) phase III lung protocols
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- Aspartate aminotransferase (AST) less than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Pulmonary:
- Forced expiratory volume (FEV)\_1 at least 1.0 L
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss greater than 5% in the past 6 months
- No other malignancy within the past year except nonmelanoma skin cancer
- Completed 3D plan with total lung V20 </= 30% mean esophageal dose </= 34 Gy and esophageal V55 </= 30%
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic response modifiers for current lung cancer
- At least 5 years since prior biologic response modifiers
Chemotherapy:
- No prior chemotherapy for current lung cancer
- At least 5 years since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to the thorax
Surgery:
- No prior complete tumor resection
Data sourced from ClinicalTrials.gov (NCT00023673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.