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

Study Description

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Brief Summary:

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 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

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Study Design

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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

Arms and Interventions

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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): 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

Outcome Measures

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Primary Outcome Measures :

1. Overall survival time between 3 treatment arms [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :

1. Complete and partial response rates [ Time Frame: Up to 5 years ]
2. Failure-free survival [ Time Frame: Up to 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Contacts

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

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Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

Study Chair:	Jeffrey A. Bogart, MD	State University of New York - Upstate Medical University

More Information

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Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database 

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
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