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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 August 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00632853
First received: March 8, 2008
Last updated: August 10, 2015
Last verified: August 2015
  Purpose

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 Intervention Phase
Lung Cancer
Radiation: Standard Radiation Dose Therapy
Drug: cisplatin
Drug: etoposide
Radiation: High Radiation Dose Therapy
Drug: carboplatin
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 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete and partial response rates [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Failure-free survival [ Time Frame: Up to 5 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 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

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

Contacts
Contact: Jeffrey A. Bogart, MD 315 464-5276

  Show 225 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Jeffrey A. Bogart, MD State University of New York - Upstate Medical University
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00632853     History of Changes
Other Study ID Numbers: CALGB-30610, CALGB-30610, RTOG 0538, U10CA031946, CDR0000588879
Study First Received: March 8, 2008
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration
United States: NCI Central Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 27, 2015