Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00005022
First received: April 6, 2000
Last updated: October 31, 2013
Last verified: October 2013

April 6, 2000
October 31, 2013
February 1998
October 2002   (final data collection date for primary outcome measure)
Frequency of patients developing unacceptable (grade 3 or higher) acute toxicities attributable to thoracic irradiation with concurrent chemotherapy [ Time Frame: From start of treatment until 90 days ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00005022 on ClinicalTrials.gov Archive Site
Compare baseline and follow-up Mini Mental Status Examinations [ Time Frame: From baseline until end of follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
A Phase I/II Escalation Study of Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients with limited-stage small cell lung cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of thoracic radiation using an accelerated boost with concurrent chemotherapy in patients with small cell lung cancer. II. Evaluate the response rate and overall survival in these patients. III. Reduce the toxic effects of treatment to esophagus and lungs.

OUTLINE: This is a radiation dose escalation study. Patients are sequentially accrued to one of four radiation dose levels. Dose level 1: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given daily for 2 days, then twice daily for 3 days during week 5. (Closed to accrual 6/98) Dose level 2: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5. (Closed to accrual 9/24/99) Dose level 3: Patients receive radiotherapy 5 days a week for 18 days followed by radiation boost given in the evenings on days 19 and 20, then twice daily for 5 days during week 5. (Closed to accrual 5/5/00) Dose level 4: Patients receive radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on days 17-20, then twice daily for 5 days during week 5. The fifth dose level is the same as the first dose level. (Closed to accrual 3/19/99) Cohorts of 5 patients are entered at each radiation dose level. If one patient experiences nonhematologic dose limiting toxicity (DLT), 5 additional patients are treated at that level. If no further DLT occurs, escalation to the next arm proceeds. Patients receive cisplatin IV plus etoposide IV on day 1 of radiotherapy and oral etoposide on days 2 and 3 every 3 weeks for 4 courses. Patients are followed every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 months.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: etoposide
  • Radiation: radiation therapy
  • Experimental: Arm 1
    Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: radiation therapy
  • Experimental: Arm 2
    Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days.
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: radiation therapy
  • Experimental: Arm 3
    Large field radiation therapy 32.4 Gy, 1.8 Gy/fx/D/5 days x 18 fx, boost just in pm @ 1.8 Gy/fx on days 19 & 20, then boost 1.8 Gy BID x last 5 days.
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: radiation therapy
  • Experimental: Arm 4
    Large field radiation therapy 28.8 Gy, 1.8 Gy/fx/5 days x 16 fx, boost just in pm @ 1.8 Gy/fx on days 17-20, then boost 1.8 Gy BID x last 5 days.
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: radiation therapy
  • Experimental: Arm 5
    Large field radiation therapy 36 Gy, 1.8 Gy/fx/D 5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: radiation therapy
  • Experimental: Arm 6
    Large field radiation therapy 25.2 Gy, 1.8 Gy/fx/5 days x 14 fx, boost just in pm @ 1.8 Gy/fx on days 15-20, then boost 1.8 Gy BID x last 5 days.
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide
    • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
June 2010
October 2002   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell carcinoma of the lung Limited disease (stage I-IIIb but excluding T4 tumor based on malignant pleural effusion or N3 disease based on contralateral hilar or contralateral supraclavicular involvement) No pericardial or pleural effusion on chest x-ray regardless of cytology Measurable or evaluable disease Tumor must be encompassed by limited radiation therapy fields without causing severe symptomatic pulmonary dysfunction

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic heart disease At least 6 months since prior myocardial infarction Pulmonary: See Disease Characteristics Forced expiratory volume at one second (FEV1) greater than 0.8 L No uncontrolled bronchospasm in unaffected lung Other: No other serious concurrent illness No prior or concurrent malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other concurrent malignancy No history of uncontrolled psychiatric illness, severe head injury, chronic alcohol or drug abuse, or central nervous system disease Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior complete tumor resection

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00005022
RTOG-9712, CDR0000065797
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Ritsuko U. Komaki, MD, FACR M.D. Anderson Cancer Center
Radiation Therapy Oncology Group
October 2013

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