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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
Must not have
Patients with pathologically confirmed spread of cancer beyond the uterus and cervix to pelvic or para-aortic lymph nodes, adnexal structures, and/or other anatomic sites, or patients with serous or clear cell histology and with positive cytologic washings
Patients who have received prior radiotherapy directed to treat disease within the abdominal cavity or pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall survival is measured from study enrollment for up to 10 years.
Awards & highlights
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.
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.
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.
Select...
I have had a hysterectomy, and removal of both ovaries is highly recommended.
Select...
I am 18 or older and have 3 risk factors.
Select...
My cancer is confined to the uterus and has a specific cell type, with no cancer cells found in my abdomen.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My kidney function test shows I can clear more than 50 mL/min.
Select...
My nerve damage does not significantly affect my daily activities.
Select...
I am 70 or older with at least one risk factor or 50 or older with two risk factors.
Select...
My cancer is a specific type of endometrial carcinoma and fits certain risk categories.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread beyond my uterus and cervix.
Select...
I have had radiation therapy for cancer in my abdomen or pelvis.
Select...
I cannot receive radiation therapy to my pelvis due to health reasons.
Select...
My endometrial cancer has come back.
Select...
My cancer is a rare type of uterine cancer, not the common endometrial cancer.
Select...
I have had non-surgical treatment for endometrial cancer.
Select...
My endometrial cancer is at an advanced stage (III or IV).
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Recurrence or Death Events at Primary Analysis
Secondary study objectives
Number of Participants With Death Events
Number of Participants With Sites of Recurrence
Patient Reported Fatigue
+2 moreTrial 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
64,580 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,399 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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
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