Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00331760
First received: May 30, 2006
Last updated: June 25, 2013
Last verified: June 2013
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cervical Cancer
Endometrial Cancer
Interventions: Drug: cisplatin
Radiation: intensity-modulated 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
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
Endometrial Cancer: IMRT Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical Cancer: IMRT + Chemotherapy (Cisplatin) Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)

Participant Flow:   Overall Study
    Endometrial Cancer: IMRT     Cervical Cancer: IMRT + Chemotherapy (Cisplatin)  
STARTED     58     48  
COMPLETED     43 [1]   40  
NOT COMPLETED     15     8  
Ineligible / no protocol treatment                 15                 8  
[1] Subjects contributing data to 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 registered patients.

Reporting Groups
  Description
Endometrial Cancer: IMRT Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical Cancer: IMRT + Chemotherapy (Cisplatin) Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Total Total of all reporting groups

Baseline Measures
    Endometrial Cancer: IMRT     Cervical Cancer: IMRT + Chemotherapy (Cisplatin)     Total  
Number of Participants  
[units: participants]
  58     48     106  
Age  
[units: years]
Median ( Full Range )
  58  
  ( 36 to 84 )  
  43  
  ( 22 to 71 )  
  53  
  ( 22 to 84 )  
Gender  
[units: participants]
     
Female     58     48     106  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)   [ Time Frame: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery. ]

2.  Secondary:   Grade 2+ Bowel Adverse Events (Diarrhea, Enteritis, Fistula, Ileus; Gastrointestinal (GI), Incontinence; Anal, Necrosis; GI, Obstruction; GI, Perforation; GI, Proctitis and Stricture/Stenosis (Including Anastomotic) as Graded by CTCAE v. 3.0)   [ Time Frame: From the start of treatment to 90 days. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   All Other Adverse Events   [ Time Frame: From start of treatment to the end of follow-up. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Chemotherapy Compliance for Cervical Carcinoma Patients   [ Time Frame: Chemotherapy treatment is centrally reviewed for quality assurance and compliance. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Local-regional Failure   [ Time Frame: From registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Distant Metastases   [ Time Frame: From registration to date of distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Disease-free Survival   [ Time Frame: From registration to date of failure (any tumor recurrence, development of distant metastases or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Overall Survival   [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
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  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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: wseiferheld@acr.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00331760     History of Changes
Other Study ID Numbers: RTOG-0418, CDR0000472905
Study First Received: May 30, 2006
Results First Received: April 12, 2013
Last Updated: June 25, 2013
Health Authority: United States: Federal Government