Trial record 1 of 1 for: calgb30610

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

This study is currently recruiting participants.

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Contacts and Locations

Verified August 2017 by Alliance for Clinical Trials in Oncology

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00632853

First received: March 8, 2008

Last updated: August 16, 2017

Last verified: August 2017

History of Changes

Purpose

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	Intervention	Phase
Lung Cancer	Radiation: Standard Radiation Dose Therapy Drug: cisplatin Drug: etoposide Radiation: High Radiation Dose Therapy Drug: carboplatin	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Cisplatin Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


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 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

Arms

Assigned Interventions

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

Drug: etoposide

Drug: carboplatin

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

Drug: etoposide

Radiation: High Radiation Dose Therapy

70 Gy

Drug: carboplatin

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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
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
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
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
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

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: NCT00632853

Contacts


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

Show 879 Study Locations

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

Additional Information:

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


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 )
Study First Received:	March 8, 2008
Last Updated:	August 16, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017

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