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Chemotherapy
Radiation + Chemotherapy for Uterine Cancer
Phase 3
Waitlist Available
Led By Marcus E Randall
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors
To be considered eligible to participate in this trial, all patients must have undergone hysterectomy; bilateral salpingo-oophorectomy (open or laparoscopic approach) is strongly encouraged
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall survival is measured from study enrollment for up to 10 years.
Awards & highlights
Study Summary
This trial is comparing different radiation therapies and chemotherapy drugs to see which is more effective in treating endometrial cancer.
Who is the study for?
This trial is for patients with high-risk stage I or II endometrial cancer who've had a hysterectomy and possibly other surgeries. They should be in good health, with no recent invasive cancers (except non-melanoma skin cancer), no prior treatments for endometrial cancer, and no evidence of disease spread beyond the uterus based on imaging.Check my eligibility
What is being tested?
The study compares pelvic radiation therapy alone to vaginal implant radiation combined with chemotherapy drugs paclitaxel and carboplatin. It aims to determine which treatment is more effective at killing tumor cells without spreading them further.See study design
What are the potential side effects?
Potential side effects include fatigue, nerve damage symptoms like numbness or tingling (neurotoxicity), digestive issues from chemotherapy, risks associated with radiation such as skin irritation or changes in bowel habits, and general discomfort from the procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer is stage II with cervical invasion.
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I have had a hysterectomy, and removal of both ovaries is highly recommended.
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I am 18 or older and have 3 risk factors.
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My cancer is confined to the uterus and has a specific cell type, with no cancer cells found in my abdomen.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function test shows I can clear more than 50 mL/min.
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My nerve damage does not significantly affect my daily activities.
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I am 70 or older with at least one risk factor or 50 or older with two risk factors.
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My cancer is a specific type of endometrial carcinoma and fits certain risk categories.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ overall survival is measured from study enrollment for up to 10 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall survival is measured from study enrollment for up to 10 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Recurrence or Death Events at Primary Analysis
Secondary outcome measures
Number of Participants With Death Events
Number of Participants With Sites of Recurrence
Patient Reported Fatigue
+2 moreOther outcome measures
Gene Expression Based Risk Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (brachytherapy, paclitaxel, carboplatin)Experimental Treatment6 Interventions
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.
Group II: Arm I (pelvic radiation therapy)Active Control6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Internal Radiation Therapy
2006
Completed Phase 3
~290
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,325 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,552 Total Patients Enrolled
Marcus E RandallPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My endometrial cancer is stage II with cervical invasion.Your test results need to meet specific requirements to qualify.I have had or will have a test for cancer cells in my abdomen as per GOG guidelines.You have endometrial cancer that fits specific criteria based on its type, size, and location. You also need to have a certain level of blood cell counts, kidney and liver function, and performance status. You must sign a consent form and allow the release of your personal health information.You need to have at least 100,000 platelets in a small amount of your blood.Your bilirubin level must be less than or equal to 1.5 times the upper limit of normal.My endometrial cancer has come back.My cancer is a rare type of uterine cancer, not the common endometrial cancer.I have had a hysterectomy and possibly removal of both ovaries and fallopian tubes.I may consider lymph node removal in my pelvic or para-aortic area.My surgery can be done through a large incision or small incisions, depending on my surgeon's choice.My cancer stage was determined using the FIGO 2009 system.My cancer is confined to the uterus and has a specific cell type, with no cancer cells found in my abdomen.I can take care of myself but might not be able to do heavy physical work.My kidney function test shows I can clear more than 50 mL/min.My nerve damage does not significantly affect my daily activities.I've had a CT/MRI showing no signs of cancer spread if I didn't have certain surgeries.My surgery can be open or minimally invasive, and it must be documented if lymph nodes were removed.I have had a hysterectomy, and removal of both ovaries is highly recommended.I am 18 or older and have 3 risk factors.I have had radiation therapy for cancer in my abdomen or pelvis.My cancer has spread beyond my uterus and cervix.I cannot receive radiation therapy to my pelvis due to health reasons.I have had non-surgical treatment for endometrial cancer.My endometrial cancer is at an advanced stage (III or IV).I am 70 or older with at least one risk factor or 50 or older with two risk factors.You have signs of cancer spread in your lymph nodes or other parts of the body as seen in imaging tests.I have not had any cancer except for non-melanoma skin cancer in the last 5 years.My cancer is a specific type of endometrial carcinoma and fits certain risk categories.My endometrial cancer is stage II with cervical invasion.My doctor took a sample from my abdomen to check for cancer.Your alkaline phosphatase blood levels must not be more than 2.5 times the upper limit of normal.I had a CT or MRI if I didn't have certain ovarian or lymph node surgeries.You must have enough white blood cells called neutrophils.Your blood creatinine level must be within the normal range for the hospital or clinic where the study is taking place.Your SGOT level in the blood should be no more than 2.5 times the usual upper limit.My cancer is aggressive or has spread to nearby vessels or deep into the muscle.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (brachytherapy, paclitaxel, carboplatin)
- Group 2: Arm I (pelvic radiation therapy)
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Endometrial Adenocarcinoma Patient Testimony for trial: Trial Name: NCT00807768 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are enrolled in this trial?
"Right now, this clinical trial is not enrolling new patients. It was originally posted on March 23rd, 2009 but the most recent update was on March 8th, 2019. For patients looking for other trials, 2073 studies are actively recruiting participants who experience fatigue and 1230 studies are specifically searching for people to try Paclitaxel."
Answered by AI
When was the last time that Paclitaxel went through FDA approval?
"Paclitaxel is a Phase 3 medication, so it has received a safety score of 3 from our analysts."
Answered by AI
How many places are coordinating this trial?
"There are presently 100 sites conducting this clinical trial, with locations in Mineola, Park Ridge and Hackensack. It may be helpful to select the location nearest you when enrolling to reduce travel time demands."
Answered by AI
Are people currently being sought out for this test?
"This study is not currently recruiting new patients, but there are 2073 other trials for fatigue and 1230 for Paclitaxel that are."
Answered by AI
Are there any other cases in the medical literature of Paclitaxel being used?
"The chemotherapy drug paclitaxel was first studied at City of Hope Comprehensive Cancer Center in 1997. Out of the 2,238 completed clinical trials, 1,230 are still active. A large percentage of these ongoing studies are based out of Mineola, New york."
Answered by AI
Who else is applying?
What state do they live in?
New York
Alabama
California
Other
How old are they?
18 - 65
What site did they apply to?
UCSF Medical Center-Mount Zion
Sutter Cancer Centers Radiation Oncology Services-Vacaville
John H Stroger Jr Hospital of Cook County
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
What questions have other patients asked about this trial?
How long does it take? And is there conversation or is the weight loss drug the compensation?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
this was sent to me. i need help with my condition. I am hoping that this clinical trial will give me a kickstart to lose weight.
PatientReceived 1 prior treatment
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