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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Drug: cisplatin
Drug: etoposide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival time between 3 treatment arms [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 729
Study Start Date: March 2008
Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632853

  Show 395 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwest Oncology Group
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier: NCT00632853     History of Changes
Other Study ID Numbers: CDR0000588879, CALGB-30610, RTOG 0538, U10CA031946
Study First Received: March 8, 2008
Last Updated: June 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Small Cell Lung Carcinoma
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014