This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00632853
Recruitment Status : Active, not recruiting
First Posted : March 11, 2008
Results First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: Standard Radiation Dose Therapy Drug: cisplatin Drug: etoposide Radiation: High Radiation Dose Therapy Drug: carboplatin Phase 3

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 731 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 2008
Actual Primary Completion Date : March 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Arm A - Standard Radiotherapy + Chemotherapy

Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks

Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):

  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days
  • Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days
 Radiation: Standard Radiation Dose Therapy
45 Gy

Drug: cisplatin
IV

Drug: etoposide
IV

Drug: carboplatin
IV
Experimental: Arm B - High Dose Radiotherapy + Chemotherapy

Radiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks

Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):

  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days
  • Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
 Drug: cisplatin
IV

Drug: etoposide
IV

Radiation: High Radiation Dose Therapy
70 Gy

Drug: carboplatin
IV


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival Time [ Time Frame: 11.25 years ]
    Overall survival time is defined as the time between a patient's registration and death or end of survival follow up.


Secondary Outcome Measures :
  1. Complete and Partial Response Rates [ Time Frame: 11.25 years ]
  2. Failure-free >> Survival [ Time Frame: Up to 5 years ]
  3. To Compare Rates of Local Relapse, Distant Metastases and Brain Metastases With These > Regimens. [ Time Frame: 5 years ]
  4. To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State. [ Time Frame: 5 years ]
  5. To Describe the Patterns of Use of Thoracic Intensity Modulated Radiation Therapy (IMRT) in Patients With Limited Stage Small Cell Lung Cancer. [ Time Frame: 5 years ]
  6. To Examine Blood-based Biomarkers of Response and Resistance to Cisplatin (or Carboplatin) and Etoposide. [ Time Frame: 5 years ]
  7. To Evaluate the Correspondence Between Increases in Plasma ProGRP Concentrations and Disease Progression/Recurrence [ Time Frame: 5 years ]
  8. To Evaluate the Potential for Plasma ProGRP Concentrations at Baseline, After Each Cycle of > Chemotherapy and at First Evaluation Following Completion of Chemotherapy to Predict PFS and OS. [ Time Frame: 5 years ]
  9. To Evaluate the Correspondence Between Longitudinal Decreases in Plasma ProGRP Concentrations and Clinical Response. [ Time Frame: 5 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

  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 etoposide.
    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 30610.
    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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632853


Locations
Show Show 934 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Jeffrey A. Bogart, MD State University of New York - Upstate Medical University
  Study Documents (Full-Text)

Documents provided by Alliance for Clinical Trials in Oncology:
Study Protocol and Statistical Analysis Plan  [PDF] August 2, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00632853    
Other Study ID Numbers: CALGB-30610
CALGB-30610 ( Other Identifier: Cancer and Leukemia Group B )
RTOG 0538 ( Other Identifier: Radiation Therapy Oncology Group )
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000588879 ( Registry Identifier: Physician Data Query )
NCI-2009-00470 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Posted: March 11, 2008    Key Record Dates
Results First Posted: June 12, 2023
Last Update Posted: June 12, 2023
Last Verified: June 2023
Keywords provided by Alliance for Clinical Trials in Oncology:
limited stage small cell lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action