CLINICAL TRIAL

GCSF for Endometrial Neoplasms

Stage I
Recruiting · 18+ · Female · Stanford, CA

This study is evaluating whether a growth factor may help reduce the risk of infection after radiation treatment.

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About the trial for Endometrial Neoplasms

Eligible Conditions
Endometrial Cancer · Uterine Cervical Neoplasms · Endometrial Neoplasms · Cervix Cancer

Treatment Groups

This trial involves 4 different treatments. GCSF is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
GCSF
DRUG
+
FDG PET/CT
DIAGNOSTICTEST
Experimental Group 2
GCSF
DRUG
+
FDG PET/CT
DIAGNOSTICTEST
Experimental Group 3
GCSF
DRUG
+
FDG PET/CT
DIAGNOSTICTEST
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
FDG PET/CT
2014
N/A
~170

Eligibility

This trial is for female patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A person with an ECOG performance status of 0 is fully active and has no limitations show original
Adequate bone marrow function (white blood cells > 3.0 X 109/L, platelets >100 x 109/L)
The ability to understand and willingness to sign a written informed consent document is important. show original
The patient was diagnosed with stage I IIIC1 cervix cancer with no prior treatment or stage IIIA IIIC1 endometrial cancer status post hysterectomy and lymph node assessment. show original
There is no need for radiation therapy to the aorta or to a large radiation field. show original
Adequate renal function means that your serum creatinine levels are less than 1.5 or your creatinine clearance is greater than 50 mg/dl. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 33 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 33 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 33 months.
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether GCSF will improve 2 primary outcomes in patients with Endometrial Neoplasms. Measurement will happen over the course of 12 months.

Determine the Recommended phase 2 dose (RP2D)
12 MONTHS
Recommended phase 2 dose (RP2D) will be defined as the dose at which the standard uptake value (SUV) on D5 FDG PET reaches target SUVmean of 2.5 or higher with normalization of white blood cells (WBC) and ANC prior to start of radiation.
12 MONTHS
Determine the rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy)
33 MONTHS
Rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy) will be monitored by the regular CBC with differential on the study schema and calendar, as per standard of care for patients receiving chemoradiation and/or chemotherapy.
33 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of endometrial neoplasms?

Symptoms of endometrial cancer include heavy menstrual bleeding, pelvic pain, loss of appetite, nausea, abdominal pain, painful urination, and weight loss. These symptoms can develop into rectal bleeding, abdominal pain, and pelvic pain. Some patients may not experience symptoms at all.\n

Anonymous Patient Answer

How many people get endometrial neoplasms a year in the United States?

around 1,700 new cases of cancer in uterine and fallopian tube were diagnosed a year in the United States. Around 2,500 new cancers in the female reproductive tract were fatal each year.

Anonymous Patient Answer

What causes endometrial neoplasms?

While the main source of endometrial neoplasms is benign, the incidence of early malignancy is high. The aetiology of endometrial adenocarcinoma is not yet well defined, although some risk factors may exist. The tumour develops from adenosis in only 5% of cases. It appears to be driven by the hormone-signaling axis and its imbalance. This indicates the necessity of assessing this axis in every case.

Anonymous Patient Answer

What is endometrial neoplasms?

endometrial neoplasms are the most common type of malignant tumors in the female reproductive tracts. The most prevalent types of cancer are adenocarcinomas and squamous cell carcinomas.

Anonymous Patient Answer

Can endometrial neoplasms be cured?

Findings from a recent study demonstrates a very high curability of adenocarcinoma, and adenomyoma. The cure rate should be investigated further and the use of adjuvant therapies to improve prognosis should be considered.

Anonymous Patient Answer

What are common treatments for endometrial neoplasms?

The majority of endometrial cancer is treated with surgery, chemoradiation, or hormonal therapy, while chemotherapy and other drugs are used for specific scenarios (recurrent disease, distant metastases, etc.).

Anonymous Patient Answer

What is the primary cause of endometrial neoplasms?

It is well-documented and supported by the literature that human papillomavirus (HPV) infection is the primary cause of endometrial intraepithelial neoplasia (EIN). However, EIN lesions develop from normal intraepithelial epithelium or maybe from a metaplasia. It has also been demonstrated that endometrial carcinomas develop from endometrial intraepithelial carcinoma. Therefore, HPV may be the primary cause of endometrial carcinoma development.

Anonymous Patient Answer

Is gcsf typically used in combination with any other treatments?

We found that patients who have Gcsf were more likely to be used in combination with other treatment modalities, including radiotherapy, chemotherapy, and palliative care. The use of Gcsf plus irradiation or concurrent chemotherapy was the most common regimen. Based on our analysis of a large cohort of patients, the use of Gcsf appears not likely to substantially impact overall survival.

Anonymous Patient Answer

What are the chances of developing endometrial neoplasms?

Women in developed countries are not at risk for developing endometrial neoplasms. However, women in developing countries are at higher risk for development of endometrial neoplasms. These data indicate that there is a difference in risk of developing endometrial neoplasms between the two groups (women in developed versus developing countries).

Anonymous Patient Answer

Who should consider clinical trials for endometrial neoplasms?

Clinical trials of endometrial cancer represent a valuable alternative to patient selection for adjuvant endometrial cancer treatment because they have the ability to improve overall survival for patients with endometrial cancer. We recommend consideration of clinical trials for endometrial cancers based primarily on histologic subtype and grade. ClinicalTrials.gov: http://clinicaltrials.gov/ct/show/NCT00389942(INR) "

"Terefundus ritsemae\n\nTerefundus ritsemae is a species of sea snail, a marine gastropod mollusk in the family Muricidae, the murex snails or rock snails.

Anonymous Patient Answer

How does gcsf work?

When this agent was administered after surgery in this patient population, it resulted in prolongation of PFS for the whole group as well as for patients with stage IB and II uterine leiomyomas. The administration of gcfs alone also produced a significant increased PFS for the whole cohort. Recent findings support the development of a further, randomised, triple-enrovery, comparative clinical trial investigating the use of gcsf alone in uterine leiomyoma patients undergoing hysterectomy and pelvic radiotherapy.

Anonymous Patient Answer

Have there been any new discoveries for treating endometrial neoplasms?

There are no new drugs or agents that have been shown to be significantly effective in the treatment and management of endometrial neoplasms, although a few therapies have demonstrated the potential to be effective at improving survival when employed in combination with surgery and/or adjuvant therapy.

Anonymous Patient Answer
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