Phase 2
N=19
Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00043108 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Toxic Death Rate — NA Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); paclitaxel (Drug); conventional surgery (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fox Chase Cancer Center
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toxic Death Rate |
NA | — |
| PRIMARY Complete Resection Rates |
NA | — |
| SECONDARY Survival |
NA | — |
| SECONDARY Event-free Survival |
NA | — |
| SECONDARY Pathologic Complete Remission (pCR) |
NA | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC)
- Must have involvement of the superior sulcus, chest wall, or mediastinum
- Must have at least 1 of the following:
- Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1)
- Resectable chest wall disease (T3, N0-1)
- Marginally resectable T4, N0-1, or NX central NSCLC
- N2 patients who are potentially resectable after induction chemoradiotherapy
- No evidence of extrathoracic spread to liver, adrenals, brain, or bone
- No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No superior vena cava syndrome
- No myocardial infarction within the past 6 months
- No active uncontrolled congestive heart failure
- No active uncontrolled arrhythmia within the past 6 months
Pulmonary
- FEV1 at least 800 mL
Other
- No other active invasive malignancy requiring therapy within the past 2 years
- No ongoing need for adjuvant therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic or thoracic radiotherapy
Surgery
- See Disease Characteristics
Other
- Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable
Data sourced from ClinicalTrials.gov (NCT00043108). 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.