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

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide 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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or cytologically documented small cell lung cancer (SCLC)

- Limited-stage disease

- Disease restricted to one hemithorax with regional lymph node metastases,
including ipsilateral hilar, ipsilateral and contralateral mediastinal, and
ipsilateral supraclavicular lymph nodes

- The following patients are not eligible:

- Patients with disease involvement of the contralateral hilar or supraclavicular
lymph nodes

- Patients with pleural effusions that are visible on plain chest radiographs,
whether cytologically positive or not

- Patients with cytologically positive pleural or pericardial fluid, regardless of
the appearance on plain x-ray

- Measurable disease, defined as at least one unidimensionally measurable lesion ≥ 2 cm
by conventional techniques OR ≥ 1 cm by spiral CT scan

PATIENT CHARACTERISTICS:

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Granulocytes ≥ 1,500/µl

- Platelet count ≥ 100,000/µl

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

- AST ≤ 2.0 times ULN

- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 70 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- Patients may have received one and only one course of chemotherapy prior to enrolling
on CALGB 30610, which must have included cisplatin and etoposide

- If a patient has had one course of cisplatin/etoposide prior to registration,
the patient must have had all of the prior-to-registration tests prior to
starting their first course of chemotherapy

- Registration to CALGB-30610 must take place within 14-21 days after the start of
the non-protocol therapy; failing to do all of the above will make the patient
NOT eligible for CALGB-30610

- No prior radiotherapy or chemotherapy (except for the chemotherapy described above)
for SCLC

- No prior mediastinal or thoracic radiotherapy

- No prior complete surgical resection of SCLC

Gender: Both
Steward Physician(s)
  • Jeffrey A. Bogart, MD
  • Gregory A. Masters, MD
  • Ritsuko U. Komaki, MD, FACR
  • John Heymach, MD, PhD
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Drug
  • cisplatin
  • etoposide
Radiation
  • 3-dimensional conformal radiation therapy
  • intensity-modulated radiation therapy
For more information about this trial, contact

Leslie A. Martin, MD

Phone: (617) 789-2903


Physician Researcher

Investigator Name:

  • Jeffrey A. Bogart, MD
  • Gregory A. Masters, MD
  • Ritsuko U. Komaki, MD, FACR
  • John Heymach, MD, PhD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00632853
Volunteers:  Not Accepting Healthy Volunteers

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