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Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy

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ClinicalTrials.gov Identifier: NCT00077064
Recruitment Status : Terminated (Due to unmet accrual/randomization goals)
First Posted : February 11, 2004
Results First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Lung Cancer
Pulmonary Complications
Radiation Fibrosis
Intervention: Drug: captopril

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were registered within 7 days prior to start of radiation therapy(RT) or during RT up to 48 hours prior completion of RT. They were randomized to captopril or observation within 48 hours prior to completion of RT. Eighty-one patients were registered, 48 did not continue to treatment assignment, 33 were randomized.

Reporting Groups
  Description
Clinical Observation Clinical observation
Captopril Captopril: 50 mg t.i.d.

Participant Flow:   Overall Study
    Clinical Observation   Captopril
STARTED   17   16 
COMPLETED   17 [1]   10 [1] 
NOT COMPLETED   0   6 
Adverse Event                0                4 
Patient refusal                0                2 
[1] Randomized eligible subjects are considered to have completed the study.



  Baseline Characteristics

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.
Randomized eligible patients.

Reporting Groups
  Description
Observation Clinical observation
Captopril Captopril: 50 mg t.i.d.
Total Total of all reporting groups

Baseline Measures
   Observation   Captopril   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   10   27 
Age 
[Units: Years]
Median (Full Range)
 67 
 (42 to 87) 
 64 
 (46 to 75) 
 65 
 (42 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  52.9%      5  50.0%      14  51.9% 
Male      8  47.1%      5  50.0%      13  48.1% 


  Outcome Measures

1.  Primary:   Incidence of Therapy-induced Lung Toxicity   [ Time Frame: Once all patients have been followed for at least 12 months ]

2.  Secondary:   Correlation of Lung Toxicities With Biochemical Markers   [ Time Frame: Once all patients have been followed for at least 12 months ]

3.  Secondary:   Correlation of Quality of Life With Late Effects as Measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or EORTC Lung Cancer Module (LC-13)   [ Time Frame: Baseline to 18 months post treatment ]

4.  Secondary:   Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment   [ Time Frame: 2 years from completion of study treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
The study stopped accrual early due to unmet accrual/randomization goals: 81 accrued of 205 planned, 33 randomized of 168 planned. Statistical testing of primary outcome measure not done due to low power.


  More Information

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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00077064     History of Changes
Other Study ID Numbers: RTOG-0123
CDR0000315569
RTOG-L-0123
First Submitted: February 10, 2004
First Posted: February 11, 2004
Results First Submitted: June 16, 2016
Results First Posted: March 8, 2018
Last Update Posted: March 8, 2018