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Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer

This study has been terminated.
(Slow accrual due to restrictive eligibility criteria)
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Raymond H. Mak, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01222572
First received: October 8, 2010
Last updated: October 18, 2014
Last verified: October 2014
Results First Received: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-small Cell Lung Cancer
Lung Cancer
NSCLC
Interventions: Radiation: Stereotactic boost
Radiation: Conventional RT
Drug: Etoposide
Drug: Cisplatin

  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
Due to restrictive eligibility criteria, accrual did not meet expectations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stereotactic Boost to Chemoradiotherapy (Dose Level 1)

Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy

Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point.

Stereotactic Boost to Chemoradiotherapy (Dose Level 2)

Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy

Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point.

Stereotactic Boost to Chemoradiotherapy (Dose Level 3)

Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy

Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point.


Participant Flow:   Overall Study
    Stereotactic Boost to Chemoradiotherapy (Dose Level 1)     Stereotactic Boost to Chemoradiotherapy (Dose Level 2)     Stereotactic Boost to Chemoradiotherapy (Dose Level 3)  
STARTED     1     0     0  
COMPLETED     1     0     0  
NOT COMPLETED     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
Stereotactic Boost to Chemoradiotherapy (Dose Level 1)

Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy

Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point.


Baseline Measures
    Stereotactic Boost to Chemoradiotherapy (Dose Level 1)  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Mean ( Full Range )
  68  
  ( 68 to 68 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     1  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 7-week chemoradiotherapy period and the subsequent 8-week recovery period ]


  Serious Adverse Events


  Other Adverse Events


  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
Study was closed due to poor accrual after enrollment of 1 patient and results of trial are not interpretable.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Raymond Mak, MD
Organization: Dana-Farber Cancer Institute/Brigham and Women's Hospital
phone: 6177328651
e-mail: rmak@partners.org


No publications provided


Responsible Party: Raymond H. Mak, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01222572     History of Changes
Other Study ID Numbers: 10-240
Study First Received: October 8, 2010
Results First Received: August 25, 2014
Last Updated: October 18, 2014
Health Authority: United States: Institutional Review Board