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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
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE March 8, 2008
First Posted Date  ICMJE March 11, 2008
Last Update Posted Date January 11, 2021
Actual Study Start Date  ICMJE March 2008
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
Overall survival time between 3 treatment arms [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2008)
Overall survival time between 3 treatment arms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
  • Complete and partial response rates [ Time Frame: Up to 5 years ]
  • Failure-free survival [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2008)
  • Toxicity
  • Complete and partial response rates
  • Failure-free survival
  • Local tumor progression according to RECIST criteria
  • Rates of distant metastases and intracranial metastases
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
Official Title  ICMJE Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
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.
Detailed Description

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), radiotherapy start time (at first cycle of protocol chemotherapy, after one cycle of prior non-protocol chemotherapy vs at first cycle of protocol chemotherapy, without prior non-protocol chemotherapy vs at second cycle of protocol chemotherapy, without prior non-protocol chemotherapy) and chemotherapy backbone: carboplatin vs cisplatin.

OBJECTIVES:

Primary Objective

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 Objectives

  1. To compare treatment related toxic effects of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer
  2. To compare response rates, failure-free survival and toxicity of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer
  3. To compare rates of local relapse, distant metastases and brain metastases with these regimens
  4. To compare patients' quality of life between these treatment regimens in terms of their physical symptoms, physical functioning and psychological state
  5. To describe the patterns of use of thoracic intensity modulated radiation therapy (IMRT) in patients with limited stage small cell lung cancer
  6. To examine blood-based biomarkers of response and resistance to cisplatin (or carboplatin) and etoposide
  7. To evaluate the correspondence between increases in plasma ProGRP concentrations and disease progression/recurrence
  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
  9. To evaluate the correspondence between longitudinal decreases in plasma ProGRP concentrations and clinical response

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 or carboplatin IV 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 or carboplatin and etoposide as in arm I.

Arm III: (discontinued as of 03/10/13) Patients undergo mid-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.

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. Please see the Arms section for more information regarding Part 2.

Prophylactic cranial irradiotherapy (PCI): Within 3-6 weeks after completion of chemotherapy, PCI should be offered to all patients with a complete tumor response (CR) or near complete response (nCR) with only residual chest abnormalities of indeterminate nature following completion of combined modality therapy.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Radiation: Standard Radiation Dose Therapy
    45 Gy
  • Drug: cisplatin
    IV
  • Drug: etoposide
    IV
  • Radiation: High Radiation Dose Therapy
    70 Gy
  • Drug: carboplatin
    IV
Study Arms  ICMJE
  • 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
    Interventions:
    • Radiation: Standard Radiation Dose Therapy
    • Drug: cisplatin
    • Drug: etoposide
    • Drug: carboplatin
  • 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
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: High Radiation Dose Therapy
    • Drug: carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 7, 2020)
731
Original Enrollment  ICMJE
 (submitted: March 8, 2008)
712
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   Korea, Republic of,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00632853
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jeffrey A. Bogart, MD State University of New York - Upstate Medical University
PRS Account Alliance for Clinical Trials in Oncology
Verification Date January 2021

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