Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Protocol # :
Lung Cancer
Disease Sites
Principal Investigator
Kozono, David, E
Site Investigator
Lathan, Christopher
Macausland, Stephanie
Martin, Leslie
Small, Christine, Olsen
Willers, Henning
Site Research Nurses
Calarese, Pamela
Hershey, Allie
Killion, Leah, J.
LaPointe, Janet
Loeser, Wendy
Mann, Eileen, Marie
McMullin, Margaret
Spicer, Beverly, A.
Stober, Lisa, L.
Wanat, Alexandra

Trial Description

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. It is not yet
known which radiation therapy regimen is more effective when given together with chemotherapy
in treating patients with limited-stage small cell lung cancer. This randomized phase III
trial is comparing different chest radiation therapy regimens to see how well they work in
treating patients with limited-stage small cell lung cancer.

Eligibility Requirements

1. Documentation of Disease

1. Histologically or cytologically documented small cell lung cancer (SCLC)

2. Limited-stage disease patients with disease restricted to one hemithorax with
regional lymph node metastases, including ipsilateral hilar, ipsilateral and
contralateral mediastinal, and ipsilateral supraclavicular lymph nodes

- Patients with disease involvement of the contralateral hilar or
supraclavicular lymph nodes are not eligible

- Patients with pleural effusions that are visible on plain chest radiographs,
whether cytologically positive or not are not eligible unless they have a
negative thoracentesis

- Patients with cytologically positive pleural or pericardial fluid,
regardless of the appearance on plain x-ray are not eligible

2. Measurable disease - Patients must have measurable disease, which includes lesions
that can be accurately measured in at least one dimension (longest diameter to be
recorded) as ≥ 2 cm with conventional techniques OR ≥ 1 cm by spiral CT scan

3. Prior Treatment

1. Patients may have received one and only one cycle of chemotherapy prior to
enrolling on CALGB 30610, which must have included carboplatin or cisplatin and

2. If a patient has had one cycle of cisplatin or carboplatin/etoposide prior to
registration, the patient must have had all of it prior to registration tests as
outlined in the protocol and prior to starting their first cycle of chemotherapy.

3. Additionally, these patients also must have met all of the eligibility criteria
in the protocol prior to receiving the first cycle of chemotherapy.

4. Registration to CALGB 30610 must take place within 14-21 days after the start of
the non-protocol therapy.

5. Failing to do all of the above will make the patient NOT eligible for CALGB

6. No prior radiotherapy or chemotherapy (except for the chemotherapy described in
the bullet above) for SCLC

7. No prior mediastinal or thoracic radiotherapy

8. Patients with complete surgical resection of disease are not eligible

4. Age Requirement ≥ 18 years of age

5. ECOG Performance Status 0-2

6. Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing

7. Required Initial Laboratory Values

1. Granulocytes ≥ 1,500/µl

2. Platelet count ≥ 100,000/µl

3. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

4. AST (SGOT) ≤ 2.0 times ULN

5. Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min