| Clinical
Trial: |
S0023
-Locally Advanced Stage III Non-Small Lung Cancer |
| Governing Group: |
Southwest Oncology
Group |
| Title: |
"A Phase III
Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetaxel
Followed by Maintenance Therapy with ZD1839 or Placebo in Patients
with Inoperable Locally Advanced Stage III Non-Small Cell Carcinoma." |
Eligibility:
- Patients must have histologic or cytologic-proven, newly diagnosed
single, primary unresectable IIIA or IIIB Non-Small Cell Lung
Cancer.
- If IIIA (n2): N2-proven by biopsy; Positive node distinct from
AP window nodes on CT.
- If IIIB: N3-proven biopsy of supraclavicular or contralateral
mediastinal nodes.; Contralateral nodes greater than 3 cm on CT;
Contralateral node positive on FDG-PET; Or R primary with paralyzed
L true vocal cord.
- If T4: Tumor of any size invading mediastinum, heart, great
vessels, trachea, esophagus, vertebral body or carina; or radiographic
soft tissue extension into mediastinal space.
- Patients with brain metastasis are ineligible.
- Patients with two (2) or more parenchymal lesions on same or
opposite sides of the lung are ineligible.
- Patients must not have malignant pleural effusions (except
pleural effusions visible only on CT scan and not on CXR or deemed
too small to tap), pericardial effusions or positive cervical
nodes.
- Patients must not have had prior chemotherapy or radiation
for lung cancer, previous surgical resection except to diagnose
stage or uncontrolled DM or cardiac disease.
- Patients must have FEVI greater than or equal to 2.0L, or predicted
FEV1 of the contralateral lung greater than 800 ml.
- Patients must have adequate renal, hepatic and hematologic
functrion.
- Patients must be offered participation in S9925 - Lung Cancer
Specimen Repository.
- Must be disease free from other malignacies for at least 5
years.
|
