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A Phase II/III Randomized Trial of Two Doses (Phase III-Standard
vs. High) and Two High Dose Schedules (Phase II-Once vs. Twice
Daily) for Delivering Prophylactic Cranial Irradiation (PCI) for
Patients with Limited Disease Small Cell Lung Cancer (SCLC)
Histologic proof or unequivocal cytologic proof of SCLC, limited
disease SCLC, clinical Stage I-IIIB (AJCC, 1997), whatever the
induction treatment; Patients must have completed all prescribed
chemotherapy > 1 week prior to study entry before beginning
PCI; Patients must have achieved a complete response to induction
chemotherapy (+/- thoracic radiation therapy) according to local
habits (at least on a chest X-ray) at the time of study entry;
Patients may have started consolidative chest irradiation by the
time of study entry; Zubrod Performance Status < 1; Patients
must have a normal brain CT scan or MRI < 1 month prior to study
entry; Neurological function class 1 or 2 (Appendix II); Absolute
granulocyte count > 1,500 µl, HGB > 10.0 gm/100ml,
and platelet count of > 75,000 µl are required; Patients
of childbearing potential must practice adequate contraception;
A “certified” test administrator (Section 11.4) is
required for administration of the neuropsychological tests; No
radiographic evidence of brain metastases; No planned concurrent
chemotherapy or antitumoral agent during PCI; No minimal pleural
effusion or lung metastases evident on CXR; No patients with epilepsy
requiring permanent oral meds; minimal pleural effusion visible
on chest CT is allowed; No prior external beam irradiation to the
head or neck; No current or past malignancy within the past five
years other than non-melanomatous skin cancer or carcinoma in situ
of cervix; Patients must not have a serious medical or psychiatric
illness that would, in the opinion of the investigator, prevent
informed consent or completion of protocol treatment, and/or follow-up
visits; Patients must sign a study-specific consent form prior
to study entry.
Arm 1: 2.5 Gy once daily, M-F, in 10 fractions for a total of
25 Gy
Arm 2: 2.0 Gy once daily, M-F, in 18 fractions for a total of 36
Gy
Arm 3: 1.5 Gy twice daily, M-F, in 24 fractions for a total of
36 Gy
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