Your session is about to expire
← Back to Search
Radiation Therapy + Cisplatin for Endometrial Cancer
Phase 2
Waitlist Available
Led By Jonathan M Feddock
Research Sponsored by GOG Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1
Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up median follow-up for progression-free survival was 62 months with a maximum of 128 months.
Awards & highlights
Study Summary
This trial looks at how well radiation therapy and cisplatin work together or separately to treat endometrial cancer patients.
Who is the study for?
This trial is for patients with recurrent endometrial cancer who've had a hysterectomy and bilateral salpingo-oophorectomy. They should be in good physical condition (GOG status 0-2), have no extrapelvic disease, and could have had prior hormone or chemotherapy finished at least 6 months ago. Excluded are those with other recent cancers, severe heart conditions, previous pelvic radiation, or significant infections.Check my eligibility
What is being tested?
The study compares the effectiveness of radiation therapy alone versus combined with cisplatin in treating recurrent endometrial cancer. It's a phase II trial to see if adding cisplatin improves outcomes. Participants will receive either high-energy x-rays or both x-rays and cisplatin.See study design
What are the potential side effects?
Radiation may cause fatigue, skin changes, and discomfort at the treatment site. Cisplatin can lead to nausea, kidney issues, hearing loss, nerve damage (neuropathy), and an increased risk of infection due to lowered blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My nerve damage does not significantly affect my daily activities.
Select...
I have had a stent or tube placed for my blocked ureter before joining the study.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have been diagnosed with a type of endometrial carcinoma.
Select...
I have not had extensive surgery, but I am eligible if all visible cancer was removed.
Select...
My endometrial cancer has returned in my pelvis or vagina, with no spread outside the pelvis.
Select...
I had surgery to remove my uterus, ovaries, and fallopian tubes for uterine cancer.
Select...
My cancer has not spread beyond the pelvic area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ median follow-up for progression-free survival was 62 months with a maximum of 128 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~median follow-up for progression-free survival was 62 months with a maximum of 128 months.
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 Disease Progression or Death.
Secondary outcome measures
Number of Participants That Experienced Adverse Effects Grade 3 or Higher
Number of Participants That Experienced Death on Study
Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (brachytherapy, radiation therapy, cisplatin)Experimental Treatment4 Interventions
Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy as in Arm I.
Group II: Arm I (brachytherapy, radiation therapy)Experimental Treatment3 Interventions
Patients undergo EBRT to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved
Internal Radiation Therapy
2006
Completed Phase 3
~290
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
GOG FoundationLead Sponsor
41 Previous Clinical Trials
15,976 Total Patients Enrolled
1 Trials studying Endometrial Carcinoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,988 Total Patients Enrolled
18 Trials studying Endometrial Carcinoma
8,838 Patients Enrolled for Endometrial Carcinoma
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,761 Total Patients Enrolled
1 Trials studying Endometrial Carcinoma
27 Patients Enrolled for Endometrial Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had serious heart problems in the last 6 months.I have a severe infection or septicemia.My nerve damage does not significantly affect my daily activities.I have had a stent or tube placed for my blocked ureter before joining the study.I have not had any cancer other than non-melanoma skin cancer in the past 5 years.My cancer has spread outside the pelvis, including to lymph nodes.I can take care of myself but might not be able to do heavy physical work.You are expected to live for at least 3 months.Your blood tests must show specific levels as per CTCAE v 3.0.My condition limits me to only taking care of myself or I am completely disabled.I have been diagnosed with a type of endometrial carcinoma.I have not had extensive surgery, but I am eligible if all visible cancer was removed.I had surgery to remove a returning tumor and scans show no remaining cancer.I have a unique kidney shape or a kidney transplant affecting radiation treatment.I have received chemotherapy for my current cancer recurrence.I have had radiation therapy in the vaginal, pelvic, or abdominal area.My endometrial cancer has returned in my pelvis or vagina, with no spread outside the pelvis.You have a history of ongoing collagen vascular disease.I had surgery to remove my uterus, ovaries, and fallopian tubes for uterine cancer.My cancer has not spread beyond the pelvic area.I have had surgery to remove a significant amount of cancer from my pelvis or vagina.I finished hormone or chemotherapy over 6 months ago and my cancer has returned since then.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (brachytherapy, radiation therapy)
- Group 2: Arm II (brachytherapy, radiation therapy, cisplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 is the current participant enrollment for this research project?
"This clinical trial has stopped admitting new participants. The first post was made on February 25th 2008, and the most recent update to this study occurred September 28th 2021. If you continue searching for studies, there are 3912 active trials recruiting patients with carcinoma and 747 actively enrolling patients who require Internal Radiation Therapy."
Answered by AI
Are opportunities for participation in the study still available to individuals?
"Clinicaltrials.gov records demonstrate that recruitment for this trial has officially ceased; the original post was published on February 25th 2008 and last amended on September 28th 2021. Although no longer enrolling, there are a myriad of other available trials recruiting right now - 4659 to be exact."
Answered by AI
What assurances can be given regarding the safety of Internal Radiation Therapy?
"The safety of Internal Radiation Therapy has been rated a 2 on our scale from 1 to 3, as there is evidence that it is secure but no proof yet of its efficacy."
Answered by AI
Could you elaborate on the previous research conducted regarding Internal Radiation Therapy?
"Internal Radiation Therapy's first clinical trial was conducted in 1997 at City of Hope Comprehensive Cancer Center and by now, almost a thousand trials have been concluded. A total of 747 studies are currently recruiting patients, with the majority taking place near Wadsworth, Pennsylvania."
Answered by AI
What medical conditions commonly necessitate Internal Radiation Therapy?
"Internal Radiation Therapy can be utilized to ameliorate neoplasm metastasis, advanced ovarian cancer, and afflictions that are refractory to conventional treatments."
Answered by AI
In what geographic areas is this experiment taking place?
"This investigation is presently enrolling volunteers from a total of 100 medical sites. Prominent locales include Wadsworth, Wynnewood, and Emmett; to name just a few of the other places offering participation in this clinical trial. It may be helpful for potential participants to choose the location closest them in order to reduce travelling demands."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger