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Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01672892
Recruitment Status : Active, not recruiting
First Posted : August 27, 2012
Results First Posted : January 23, 2018
Last Update Posted : April 24, 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: Treatment
Conditions: Cervical Cancer
Endometrial Cancer
Gastrointestinal Complications
Perioperative/Postoperative Complications
Radiation Toxicity
Urinary Complications
Urinary Tract Toxicity
Interventions: Radiation: Standard radiation therapy
Radiation: intensity-modulated radiation therapy

  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
No text entered.

Reporting Groups
  Description
Intensity-Modulated Radiation Therapy Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy

Participant Flow:   Overall Study
    Intensity-Modulated Radiation Therapy   Standard Radiation Therapy
STARTED   137   152 
COMPLETED   129 [1]   149 [1] 
NOT COMPLETED   8   3 
Protocol Violation                8                3 
[1] Eligible subjects available for analysis



  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.
Eligible patients

Reporting Groups
  Description
Intensity-Modulated Radiation Therapy Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Total Total of all reporting groups

Baseline Measures
   Intensity-Modulated Radiation Therapy   Standard Radiation Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   149   278 
Age 
[Units: Years]
Median (Full Range)
 62 
 (28 to 82) 
 61 
 (29 to 83) 
 61 
 (28 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      129 100.0%      149 100.0%      278 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation   [ Time Frame: Baseline and week 5 of RT ]

2.  Secondary:   Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment   [ Time Frame: Baseline to Week 5 of RT ]

3.  Secondary:   Urinary Toxicity, as Measured by Change in EPIC Urinary Domain   [ Time Frame: Baseline, week 3 and 5 of RT, and 4-6 weeks after RT ]

4.  Secondary:   Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale   [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ]

5.  Secondary:   Health Utilities, as Measured by Change From Baseline in EQ-5D   [ Time Frame: Baseline, week 5 of RT, 4-6 weeks after RT ]

6.  Secondary:   Validation of EPIC Bowel and Urinary Domains   [ Time Frame: Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ]
Results not yet reported.   Anticipated Reporting Date:   11/2018  

7.  Secondary:   Local-regional Control   [ Time Frame: From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.) ]
Results not yet reported.   Anticipated Reporting Date:   11/2018  

8.  Secondary:   Disease-free Survival   [ Time Frame: From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.) ]
Results not yet reported.   Anticipated Reporting Date:   11/2018  

9.  Secondary:   Overall Survival   [ Time Frame: From randomization until 3 years. (Patients are followed until death or study termination, whichever occurs first.) ]
Results not yet reported.   Anticipated Reporting Date:   11/2018  

10.  Secondary:   Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers   [ Time Frame: Tissue samples will be obtained at the time of diagnosis and during the third week of radiation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01672892     History of Changes
Other Study ID Numbers: RTOG 1203
CDR0000738944
NCI-2012-02001 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 23, 2012
First Posted: August 27, 2012
Results First Submitted: October 3, 2017
Results First Posted: January 23, 2018
Last Update Posted: April 24, 2018