Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
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ClinicalTrials.gov Identifier: NCT00632853 |
Recruitment Status
:
Recruiting
First Posted
: March 11, 2008
Last Update Posted
: April 9, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Radiation: Standard Radiation Dose Therapy Drug: cisplatin Drug: etoposide Radiation: High Radiation Dose Therapy Drug: carboplatin | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 729 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | March 2008 |
Estimated Primary Completion Date : | June 2023 |

Arm | Intervention/treatment |
---|---|
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):
|
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):
|
Drug: cisplatin
IV
Drug: etoposide
IV
Radiation: High Radiation Dose Therapy
70 Gy
Drug: carboplatin
IV
|
- Overall survival time between 3 treatment arms [ Time Frame: Up to 5 years ]
- Complete and partial response rates [ Time Frame: Up to 5 years ]
- Failure-free survival [ Time Frame: Up to 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Documentation of Disease
- Histologically or cytologically documented small cell lung cancer (SCLC)
-
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
- 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
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Prior Treatment
- 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.
- 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.
- Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle 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 in the bullet above) for SCLC
- No prior mediastinal or thoracic radiotherapy
- Patients with complete surgical resection of disease are not eligible
- Age Requirement ≥ 18 years of age
- ECOG Performance Status 0-2
- Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing
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Required Initial Laboratory Values
- Granulocytes ≥ 1,500/µl
- Platelet count ≥ 100,000/µl
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST (SGOT) ≤ 2.0 times ULN
- Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632853
Contact: Jeffrey A. Bogart, MD | 315 464-5276 |

Study Chair: | Jeffrey A. Bogart, MD | State University of New York - Upstate Medical University |
Additional Information:
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00632853 History of Changes |
Other Study ID Numbers: |
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 ) |
First Posted: | March 11, 2008 Key Record Dates |
Last Update Posted: | April 9, 2018 |
Last Verified: | April 2018 |
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 Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Etoposide phosphate Cisplatin Carboplatin Etoposide Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |