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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00066222
First received: August 6, 2003
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival at 2 years [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival at 1 year and median overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ] [ Designated as safety issue: No ]
  • Progression-free survival at 1 year and median survival time [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ] [ Designated as safety issue: No ]
  • Rate of acute treatment related Grade 3 or 4 esophagitis [ Time Frame: From start of radiation therapy until 90 days following the start of radiation therapy ] [ Designated as safety issue: Yes ]
  • Rate of treatment related fatalities at 2 years [ Time Frame: From the start of treatment to 2 years ] [ Designated as safety issue: Yes ]
  • Response rates (complete response, partial response, progressive disease and stable disease) [ Time Frame: From the start of treatment to 2 months following the completion of chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: June 2003
Study Completion Date: November 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated high dose irradiation and chemotherapy
Accelerated high dose thoracic irradiation with concurrent etoposide and cisplatin
Drug: cisplatin Drug: etoposide Procedure: adjuvant therapy Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

  • Determine the response rate of patients with limited stage small cell lung cancer treated with cisplatin and etoposide combined with accelerated high-dose thoracic radiotherapy.
  • Determine the progression-free and overall survival in patients treated with this regimen.
  • Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). Beginning on the first day of radiotherapy, patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell carcinoma of the lung by fine needle aspiration biopsy or two positive sputa
  • Must have limited disease

    • Stage I, II, IIIA, or IIIB

      • Confined to 1 hemithorax, but excluding the following:

        • T4 tumor based on malignant pleural effusion
        • N3 disease based on contralateral hilar or supraclavicular involvement
  • No pericardial or pleural effusions on chest x-ray (regardless of cytology)
  • Measurable or evaluable disease
  • Tumor must be able to be encompassed by limited radiotherapy fields without significantly compromising pulmonary function
  • No prior complete tumor resection

PATIENT CHARACTERISTICS:

Age

  • 18 to 100

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No symptomatic heart disease

Pulmonary

  • No chronic obstructive pulmonary disease with Forced Expiratory Volume (FEV)_1 no greater than 0.8 liter
  • No uncontrolled bronchospasm in the unaffected lung

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Available for follow-up
  • No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or non-invasive in situ malignancies
  • No other concurrent serious medical illness
  • No uncontrolled psychiatric illness
  • No chronic alcohol or drug abuse

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the chest or other area containing a large amount of bone marrow (e.g., more than 75% of pelvic bone)

Surgery

  • See Disease Characteristics
  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: NCT00066222

  Show 104 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Ritsuko U. Komaki, MD, FACR M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Komaki R, Paulus R, Ettinger DS, et al.: A phase II study of accelerated high-dose thoracic radiation therapy (AHTRT) with concurrent chemotherapy for limited small cell lung cancer: RTOG 0239. [Abstract] J Clin Oncol 27 (Suppl 15): A-7527, 2009.
Komaki R, Moughan J, Ettinger D, et al.: Toxicities in a phase II study of accelerated high dose thoracic radiation therapy (TRT) with concurrent chemotherapy for limited small cell lung cancer (LSCLC) (RTOG 0239). [Abstract] J Clin Oncol 25 (Suppl 18): A-7717, 438s, 2007.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00066222     History of Changes
Other Study ID Numbers: RTOG-0239, CDR0000271939
Study First Received: August 6, 2003
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
limited stage small cell lung cancer

Additional relevant 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
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 26, 2014