Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Lung Cancer
Interventions:	Radiation: Prophylactic Cranial Irradiation; Radiation: Radiation Therapy

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Prophylactic Cranial Irradiation	Prophylactic Cranial Irradiation (PCI)
Prophylactic Cranial Irradiation + Consolidation Radiotherapy	Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease

Participant Flow:   Overall Study

	Prophylactic Cranial Irradiation	Prophylactic Cranial Irradiation + Consolidation Radiotherapy
STARTED	51	46
COMPLETED	42 [1]	44 [1]
NOT COMPLETED	9	2
Protocol Violation	7	2
Withdrawal by Subject	2	0

[1]	Subjects with data available for the primary analysis are considered to have completed the study.

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized and eligible patients

Reporting Groups

	Description
Prophylactic Cranial Irradiation	Prophylactic Cranial Irradiation (PCI)
Prophylactic Cranial Irradiation + Consolidation Radiotherapy	Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Total	Total of all reporting groups

Baseline Measures

	Prophylactic Cranial Irradiation	Prophylactic Cranial Irradiation + Consolidation Radiotherapy	Total
Overall Participants Analyzed; [Units: Participants]	42	44	86
Age; [Units: Years]; Median (Full Range)	61; (47 to 81)	66; (35 to 86)	63; (35 to 86)
Gender; [Units: Participants]; Count of Participants
Female	24 57.1%	23 52.3%	47 54.7%
Male	18 42.9%	21 47.7%	39 45.3%

  Outcome Measures

1. Primary:

Overall Survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ]

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2. Secondary:

Comparison of Treatment-related Adverse Events [ Time Frame: From start of treatment to end of follow-up. ]

Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3. Secondary:

Patterns of Failure [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ]

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4. Secondary:

Comparison of Time to First Failure [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ]

Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5. Secondary:

Evaluation of the Percentage of the Planned Radiotherapy Dose to Each Site [ Time Frame: From start to end of radiation therapy. ]

Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
At the first interim analysis of overall survival the data monitoring committee determined that due to the lack of evidence of potential efficacy and a higher than acceptable toxicity profile for the PCI+RT arm, study accrual would close early.

  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.

Results Point of Contact:  

Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org

Responsible Party:	Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT01055197 History of Changes
Other Study ID Numbers:	RTOG 0937; CDR0000663959; NCI-2011-02008 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
First Submitted:	January 22, 2010
First Posted:	January 25, 2010
Results First Submitted:	August 26, 2016
Results First Posted:	October 21, 2016
Last Update Posted:	February 17, 2017