Trial record 1 of 1 for:    calgb 30610
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Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborators:
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT00632853
First received: March 8, 2008
Last updated: June 14, 2013
Last verified: June 2013

March 8, 2008
June 14, 2013
March 2008
June 2023   (final data collection date for primary outcome measure)
Overall survival time between 3 treatment arms [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Overall survival time between 3 treatment arms [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00632853 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: Up to Interim Analysis ] [ Designated as safety issue: Yes ]
  • Complete and partial response rates [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Failure-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Local tumor progression according to RECIST criteria [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Rates of distant metastases and intracranial metastases [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Complete and partial response rates [ Designated as safety issue: No ]
  • Failure-free survival [ Designated as safety issue: No ]
  • Local tumor progression according to RECIST criteria [ Designated as safety issue: No ]
  • Rates of distant metastases and intracranial metastases [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

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.

OBJECTIVES:

Primary

  • To determine whether administering high-dose thoracic radiotherapy, 70 Gy (2 Gy once daily over 7 weeks) or 61.2 Gy (1.8 Gy once daily for 16 days followed by 1.8 Gy twice daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice daily over 3 weeks) in patients with limited-stage small cell lung cancer.

Secondary

  • To compare treatment-related toxic effects of thoracic radiotherapy regimens in patients with limited-stage small cell lung cancer.
  • To compare response rates, failure-free survival, and toxicity of thoracic radiotherapy regimens in patients with limited-stage small cell lung cancer.
  • To compare rates of local relapse, distant metastases, and brain metastases with these regimens.
  • To describe the patterns of use of thoracic intensity-modulated radiotherapy (IMRT) in patients with limited-stage small cell lung cancer.

OUTLINE: This is a 2-part, multicenter, randomized study. Patients are stratified according to gender, weight loss 6 months prior to study entry (≤ 5% of body weight vs > 5% of body weight), ECOG performance status (0 vs 1 vs 2), radiotherapy technique (intensity-modulated radiotherapy vs 3-dimensional conformal radiotherapy), and radiotherapy start time (at first course of protocol chemotherapy, after one course of prior non-protocol chemotherapy vs at first course of protocol chemotherapy, without prior non-protocol chemotherapy vs at second course of protocol chemotherapy, without prior non-protocol chemotherapy).

  • Part 1: Patients are randomized to 1 of 3 treatment arms.

    • Arm I: Patients undergo standard-dose (45 Gy given in 30 treatments) thoracic radiotherapy twice daily, 5 days a week, for 3 weeks. Patients also receive cisplatin IV on day 1 and etoposide IV on days 1, 2, and 3.
    • Arm II: Patients undergo higher-dose (70 Gy given in 35 treatments) thoracic radiotherapy once daily, 5 days a week, for 7 weeks. Patients also receive cisplatin and etoposide as in arm I.
    • Arm III: (discontinued as of 03/10/13) Patients undergo higher-dose (61.2 Gy given in 34 treatments) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days (approximately 3 weeks) of treatment and then twice daily, 5 days a week, for the final 9 days (approximately 2 weeks) of treatment. Patients also receive cisplatin and etoposide as in arm I.

In all arms, treatment with cisplatin and etoposide repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

  • Part 2: An interim analysis was conducted after accrual of 30 patients per arm and one experimental arm based upon a comparison of treatment-related toxicity was selected. The most toxic experimental arm was discontinued, and the trial continues comparing standard therapy (arm I) to the selected experimental regimen (arm II) as described in part 1.

Prophylactic radiotherapy: Within 3-6 weeks after completion of chemotherapy, patients with responding disease are eligible to undergo prophylactic radiotherapy to the brain once a day, 5 days a week, for 2 weeks.

After completion of study treatment, patients are followed up at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years or until disease progression. At disease progression, patients are followed up every 6 months.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Radiation: 3-dimensional conformal radiation therapy
    Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
  • Radiation: intensity-modulated radiation therapy
    Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
  • Drug: cisplatin
    80 mg/m2 by intravenous (IV) on day 1 of each 21 day cycle. Protocol therapy consists of 4 cycles of cisplatin administered every 21 days.
  • Drug: etoposide
    100 mg/m2 by IV on days 1, 2 and 3 of each 21 day cycle. Protocol therapy consists of a total of 4 cycles of etoposide.
  • Active Comparator: Arm I
    Patients undergo standard-dose (45 Gy given) thoracic radiotherapy twice daily, every day, for 3 weeks. Chemotherapy (cisplatin and etoposide) will be administered at specific time points every 21 days for 4 cycles for a total of 12 weeks.
    Interventions:
    • Radiation: 3-dimensional conformal radiation therapy
    • Radiation: intensity-modulated radiation therapy
    • Drug: cisplatin
    • Drug: etoposide
  • Experimental: Arm II
    Patients undergo higher-dose (70 Gy) thoracic radiotherapy once daily, every day, for 7 weeks. Chemotherapy (cisplatin and etoposide) will be administered at specific time points every 21 days for 4 cycles for a total of 12 weeks.
    Interventions:
    • Radiation: 3-dimensional conformal radiation therapy
    • Radiation: intensity-modulated radiation therapy
    • Drug: cisplatin
    • Drug: etoposide
  • Experimental: Arm III
    (discontinued as of 03/10/13) Patients undergo higher-dose (61.2 Gy) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days of treatment and then twice daily for 9 days of treatment.Chemotherapy (cisplatin and etoposide) will be administered at specific time points every 21 days for 4 cycles for a total of 12 weeks.
    Interventions:
    • Radiation: 3-dimensional conformal radiation therapy
    • Radiation: intensity-modulated radiation therapy
    • Drug: cisplatin
    • Drug: etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
729
Not Provided
June 2023   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00632853
CDR0000588879, CALGB-30610, RTOG 0538, U10CA031946
Yes
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
Cancer and Leukemia Group B
  • National Cancer Institute (NCI)
  • Radiation Therapy Oncology Group
  • Eastern Cooperative Oncology Group
  • North Central Cancer Treatment Group
  • Southwest Oncology Group
Study Chair: Jeffrey A. Bogart, MD State University of New York - Upstate Medical University
Study Chair: Gregory A. Masters, MD Helen F. Graham Cancer Center at Christiana Hospital
Study Chair: Ritsuko U. Komaki, MD, FACR M.D. Anderson Cancer Center
Study Chair: John Heymach, MD, PhD M.D. Anderson Cancer Center
Alliance for Clinical Trials in Oncology
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP