Endometrial Cancer Clinical Trial
Official title:
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.
The incidence of endometrial cancer is increasing at an alarming rate (2.6% per year). This trend parallels the rising rate of obesity, the most significant increasing risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility and thus avoid hysterectomy are treated with progestin therapy, such as progestin intra-uterine device (pIUD). However, the pIUD achieves cancer regression in only 50-70% of women, and over 50% of initial responders will develop recurrence within two years. The effectiveness of the pIUD may be improved if the driver of endometrial cancer (obesity) was simultaneously addressed. Multiple epidemiologic studies have demonstrated that bariatric surgery reduces the risk of developing endometrial cancer. Our research aims to answer the question: "Is bariatric surgery in addition to the pIUD a feasible and acceptable option for young women with endometrial cancer/atypical hyperplasia who wish to maintain their childbearing potential compared to standard treatment of pIUD alone? This is a pilot randomized controlled trial to assess the feasibility of a full-scale randomized controlled trial. Eligible women will be identified and consented over a 21-month period, and participants will be randomized to bariatric surgery plus standard pIUD (intervention group) or to standard pIUD alone (non-intervention group) in a 1:1 fashion. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05796518 -
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
|
N/A | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06463028 -
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer
|
Phase 2 | |
| Recruiting |
NCT06036836 -
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
|
Phase 2 | |
| Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT03820024 -
MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
|
N/A | |
| Active, not recruiting |
NCT05082025 -
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT00587886 -
Estrogen, Diet, Genetics and Endometrial Cancer
|
||
| Completed |
NCT05378152 -
Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
|
N/A | |
| Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
| Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
| Recruiting |
NCT04569773 -
Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
|
||
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
| Not yet recruiting |
NCT05998798 -
Revealing Engagement Patterns Among Endometrial Cancer Patients
|
||
| Not yet recruiting |
NCT06366347 -
ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab
|
Phase 2 | |
| Not yet recruiting |
NCT06073184 -
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
|
Phase 2 | |
| Terminated |
NCT02907073 -
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
|
Phase 1/Phase 2 | |
| Completed |
NCT02413606 -
ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
|
N/A |