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Trial record 1 of 1 for:    Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy
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Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00807768
Recruitment Status : Active, not recruiting
First Posted : December 12, 2008
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Fatigue
Neurotoxicity Syndrome
Obesity
Stage I Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Carboplatin
Radiation: Intensity-Modulated Radiation Therapy
Radiation: Internal Radiation Therapy
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
GOG 0249 accrued 601 patients from March 2009 to February 2013.

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
Arm I (Pelvic Radiation Therapy)

Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.

3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy

Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy

Internal Radiation Therapy: Undergo vaginal cuff brachytherapy

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm II (Brachytherapy, Paclitaxel, Carboplatin)

Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Internal Radiation Therapy: Undergo vaginal cuff brachytherapy

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies


Participant Flow:   Overall Study
    Arm I (Pelvic Radiation Therapy)   Arm II (Brachytherapy, Paclitaxel, Carboplatin)
STARTED   301   300 
COMPLETED   301   300 
NOT COMPLETED   0   0 



  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.
Enrolled patients

Reporting Groups
  Description
Arm I (Pelvic Radiation Therapy)

Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.

3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy

Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy

Internal Radiation Therapy: Undergo vaginal cuff brachytherapy

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm II (Brachytherapy, Paclitaxel, Carboplatin)

Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Internal Radiation Therapy: Undergo vaginal cuff brachytherapy

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Total Total of all reporting groups

Baseline Measures
   Arm I (Pelvic Radiation Therapy)   Arm II (Brachytherapy, Paclitaxel, Carboplatin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 301   300   601 
Age, Customized 
[Units: Participants]
Count of Participants
     
<50 years   22   16   38 
50-59 years   95   72   167 
60-69 years   115   137   252 
>=70 years   69   75   144 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      301 100.0%      300 100.0%      601 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Cell Type 
[Units: Participants]
Count of Participants
     
Endometrioid, grade 1   50   56   106 
Endometrioid, grade 2   109   103   212 
Endometrioid, grade 3 or not graded   63   63   126 
Serous   46   42   88 
Clear Cell   15   13   28 
Mixed   14   17   31 
Other   4   6   10 


  Outcome Measures

1.  Primary:   Number of Recurrence or Death Events at Primary Analysis   [ Time Frame: Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years ]

2.  Secondary:   Number of Death Events   [ Time Frame: Overall survival is measured from study enrollment for up to 10 years. ]

3.  Secondary:   Sites of Recurrence   [ Time Frame: Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years ]

4.  Secondary:   Patient Reported Fatigue   [ Time Frame: Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment ]

5.  Secondary:   Patient-reported Neurotoxicity   [ Time Frame: Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment. ]

6.  Secondary:   Patient-reported Quality of Life   [ Time Frame: Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment ]

7.  Other Pre-specified:   Gene Expression Based Risk Score   [ Time Frame: Baseline ]
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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Gedeon for Virginia Filiaci, PhD
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00807768     History of Changes
Other Study ID Numbers: GOG-0249
NCI-2009-00610 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000629591
GOG-0249 ( Other Identifier: NRG Oncology )
GOG-0249 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2008
First Posted: December 12, 2008
Results First Submitted: March 27, 2018
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018