Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide - Full Text View

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide 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.

PURPOSE: This randomized phase III trial is comparing two 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: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival time between 3 treatment arms [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Complete and partial response rates [ Designated as safety issue: No ]
Failure-free survival [ Designated as safety issue: No ]
Local tumor progression according to RECIST criteria [ Designated as safety issue: No ]
Rates of distant metastases and intracranial metastases [ 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 I Patients undergo standard-dose (45 Gy given in 30 treatments) thoracic radiotherapy twice daily, 5 days a week, for 3 weeks.	Radiation: 3-dimensional conformal radiation therapy Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13) Radiation: intensity-modulated radiation therapy Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Experimental: Arm II Patients undergo higher-dose (70 Gy given in 35 treatments) thoracic radiotherapy once daily, 5 days a week, for 7 weeks.	Radiation: 3-dimensional conformal radiation therapy Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13) Radiation: intensity-modulated radiation therapy Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Experimental: Arm III (discontinued as of 01/15/13) Patients undergo higher-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.	Radiation: 3-dimensional conformal radiation therapy Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13) Radiation: intensity-modulated radiation therapy Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)

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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 lung cancer (SCLC)
- Limited-stage disease
  - Disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
The following patients are not eligible:
- Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes
- Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not
- Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray
Measurable disease, defined as at least one unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Granulocytes ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 2.0 times ULN
Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 70 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Patients may have received one and only one course of chemotherapy prior to enrolling on CALGB 30610, which must have included cisplatin and etoposide
- If a patient has had one course of cisplatin/etoposide prior to registration, the patient must have had all of the prior-to-registration tests prior to starting their first course of chemotherapy
- Registration to CALGB-30610 must take place within 14-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB-30610
No prior radiotherapy or chemotherapy (except for the chemotherapy described above) for SCLC
No prior mediastinal or thoracic radiotherapy
No prior complete surgical resection of SCLC
No concurrent treatment with hormones or other chemotherapeutic agents except for steroids given for adrenal failure; hormones administered for non-disease-related conditions (e.g., insulin for diabetes); and intermittent use of dexamethasone as an antiemetic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632853

Show 339 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Investigators

Study Chair:	Jeffrey A. Bogart, MD	State University of New York - Upstate Medical University
Investigator:	Gregory A. Masters, MD	Helen F. Graham Cancer Center at Christiana Hospital
Study Chair:	Ritsuko U. Komaki, MD, FACR	M.D. Anderson Cancer Center
Investigator:	John Heymach, MD, PhD	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00632853 History of Changes
Other Study ID Numbers:	CDR0000588879, CALGB-30610, RTOG 0538
Study First Received:	March 8, 2008
Last Updated:	February 14, 2013
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

ClinicalTrials.gov processed this record on May 21, 2013