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Alkylating agents
Chemotherapy + Radiation for Uterine Cancer
Phase 3
Waitlist Available
Led By Daniela E Matei
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma
Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from entry into the study to death or the date of last contact, assessed up to 8 years
Awards & highlights
Study Summary
This trial is comparing the effectiveness of two chemotherapy drugs, either with or without a third drug and radiation therapy, in treating endometrial cancer.
Who is the study for?
This trial is for patients with stage I-IVA endometrial cancer who've had surgery including hysterectomy and possibly lymph node sampling. They must have certain blood cell counts, liver function within normal limits, no prior pelvic/abdominal radiation or chemotherapy for endometrial cancer, no other active cancers in the last five years (except non-melanoma skin cancer), and not exceed a tumor size of 2 cm after surgery.Check my eligibility
What is being tested?
The study compares carboplatin and paclitaxel chemotherapy with or without additional cisplatin and radiation therapy to see which is more effective at treating endometrial cancer post-surgery. The goal is to determine if adding cisplatin and radiation improves outcomes.See study design
What are the potential side effects?
Chemotherapy drugs like carboplatin, paclitaxel, and cisplatin can cause side effects such as nausea, fatigue, hair loss, nerve damage leading to numbness or tingling sensations. Radiation therapy may result in skin irritation at the treatment site, fatigue, upset stomach.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer is at stage III or IVA.
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My cancer is stage IVA, affecting my bladder or bowel but hasn't spread beyond my pelvis.
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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 cancer is at a surgical stage III with specific complications.
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I have early-stage endometrial cancer with specific cell types and positive peritoneal cytology.
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I had surgery less than 8 weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from entry into the study to death or the date of last contact, assessed up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from entry into the study to death or the date of last contact, assessed up to 8 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, Progression or Death
Secondary outcome measures
Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Overall Survival
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)Experimental Treatment6 Interventions
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (paclitaxel and carboplatin)Active Control3 Interventions
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
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
70,113 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,340 Total Patients Enrolled
Daniela E MateiPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no active cancer other than non-melanoma skin cancer in the last 5 years.I have been diagnosed with carcinosarcoma.My only extra-uterine cancer is not clear cell or papillary serous.My cancer has spread to the liver.My endometrial cancer has come back.I haven't had a heart attack, unstable chest pain, or uncontrolled heart rhythm issues in the last 3 months.I have had my uterus, both ovaries, and fallopian tubes removed.I have a tumor larger than 2 cm remaining after surgery.I have had radiation therapy in my pelvic or abdominal area.I have had chemotherapy for endometrial cancer before.My endometrial cancer is at stage III or IVA.My cancer is stage IVA, affecting my bladder or bowel but hasn't spread beyond my pelvis.I can take care of myself but might not be able to do heavy physical work.My cancer is at a surgical stage III with specific complications.I have early-stage endometrial cancer with specific cell types and positive peritoneal cytology.I had surgery less than 8 weeks ago.My condition is stage IVB endometrial cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)
- Group 2: Arm II (paclitaxel and carboplatin)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the most popular applications for Radiation Therapy?
"While often used to treat advanced endometrial cancer, Radiation Therapy can also be effective in the treatment of other conditions such as melanoma, neoplasm metastasis and non-hodgkin lymphoma."
Answered by AI
In how many distinct places is this research being conducted?
"There are a total of 100 clinical trial sites with this study, some of which include John Muir Medical Center-Concord Campus in Concord, University of Missouri - Ellis Fischel in Columbia, The Cancer Center of Hawaii-Liliha in Honolulu."
Answered by AI
What are the dangers associated with Radiation Therapy?
"Radiation Therapy received a score of 3 because multiple rounds of data support its efficacy and safety."
Answered by AI
Is this a full clinical trial or are there opportunities for new patients to enroll?
"Unfortunately, this clinical trial is not currently enrolling new participants. The study was originally posted on 29 June 2009 and was last edited on 28 September 2021. However, there are 839 other trials actively recruiting patients with stage iiib uterine corpus cancer ajcc v7 and 1639 radiation therapy trials that are currently admitting new participants."
Answered by AI
How many people are signed up to participate in this research project?
"Unfortunately, this particular clinical trial is no longer seeking new patients. The original posting was on 6/29/2009 with the most recent edit taking place on 9/28/2021. However, there are 839 other studies recruiting stage iiib uterine corpus cancer ajcc v7 patients and 1639 trials for Radiation Therapy that still have open enrollment."
Answered by AI
What are some other examples of research done on Radiation Therapy?
"City of Hope Comprehensive Cancer Center in 1997 was the first to study Radiation Therapy. In total, there have been 2495 completed studies since then. As of now, there are 1639 clinical trials that are still recruiting patients; many within Concord, California."
Answered by AI
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