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Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)



- To compare the 1-year overall median survival rate in patients with extensive stage
small cell lung cancer treated with prophylactic cranial irradiation with vs without
consolidative extracranial radiotherapy following platinum-based chemotherapy.


- To compare treatment-related adverse events in these patients.

- To evaluate patterns of failure in these patients.

- To compare the time to first failure in these patients.

- To evaluate the percentage of the planned radiotherapy dose given to each site.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
treatment (complete response vs partial response) and number of metastatic lesions (1 vs
2-3). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.

- Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also
undergo consolidative extracranial radiotherapy to locoregional and residual metastatic
disease 5 days per week for 2-3 weeks.

After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and
12 months; every 6 months for 2 years; and then annually thereafter.

Inclusion Criteria


- Histologically or cytologically confirmed extensive stage small cell lung cancer
(SCLC) diagnosed within the past 6 months*

- Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment
with chemotherapy

- Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND
meets the following criteria:

- Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease
according to RECIST criteria (if radiotherapy has been delivered to primary
disease with chemotherapy, there must be complete or partial response in ≥ 1 of
the sites that has not been treated with radiotherapy)

- No progression in any site

- No limited stage SCLC, even if disease progressed

- No brain or CNS metastases


- Zubrod performance status 0-2

- ANC ≥ 1,000/mm^3

- Platelets ≥ 75,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)

- Serum ALT and AST ≤ 2.5 times upper limit of normal (ULN) (for patients who will
receive radiotherapy to the liver)

- Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the

- Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No severe, active co-morbidity, defined as any of the following:

- Acute bacterial or fungal infection requiring IV antibiotics at the time of
study registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of study


- See Disease Characteristics

- Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy
and alopecia])

- Thoracic radiotherapy administered concurrently with or before chemotherapy for the
current diagnosis allowed (these patients will not receive mediastinal radiotherapy
per protocol)

- No prior radiotherapy to the region of this cancer that would result in overlap of
radiotherapy fields

- No concurrent chemotherapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Elizabeth M. Gore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin



Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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