Endometrial CancerPhase 4SHAPE-ENDONCT07462663
SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer
A Phase 4 study testing GLP-1 Receptor Agonist, Levonorgestrel IUD (Lng-IUD) and Oral Progestins in people with Endometrial Cancer and Endometrial Cancer Stage I, run by Hospital Universitari de Bellvitge.
Trial summary
SHAPE-ENDO is a single-center, open-label, pilot randomized clinical trial conducted at Hospital Universitari de Bellvitge in Barcelona, Spain. The study will evaluate the feasibility, safety, and acceptability of comparing two treatment strategies in women with atypical endometrial hyperplasia/endometrial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Cancer Stage I, Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I
- What is being tested?
- GLP-1 Receptor Agonist, Levonorgestrel IUD (Lng-IUD) and Oral Progestins
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2035
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants ≥18 years old.
- Histologically confirmed atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN) or low-risk endometrioid endometrial carcinoma, grade 1 or 2.
- Disease apparently confined to the uterine corpus, assessed by expert transvaginal ultrasound and/or pelvic magnetic resonance imaging.
- Low- or intermediate-risk disease according to ESGO-ESTRO-ESP 2025 criteria, including presurgical stages IA1, IA2, or IB.
- Negative or focal lymphovascular space invasion, if available.
- Favorable molecular profile, if available, including POLE-mutated, p53 wild-type, MMR-deficient, or NSMP estrogen receptor-positive disease.
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- Body mass index ≥40 kg/m² at inclusion.
- Considered a candidate for surgical treatment by the multidisciplinary tumor board.
- Ability to understand and sign written informed consent after receiving oral and written information about the study, including acceptance of random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy.
Who cannot join
- FIGO stage IA3, IC, II, or higher disease.
- Extensive lymphovascular space invasion, if available.
- High-risk molecular profile, including p53-abnormal/mutated disease or NSMP estrogen receptor-negative disease.
- Non-endometrioid histology, including serous carcinoma, clear-cell carcinoma, carcinosarcoma, mixed histology, or other high-risk histological subtypes.
- Metastatic disease or suspicion of extrauterine disease.
- Considered medically inoperable or "unfit" for surgery because of severe comorbidity, frailty, anesthetic contraindication, or any other clinical reason contraindicating surgical treatment.
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- Contraindication to GLP-1 receptor agonist therapy or progestin-based hormonal therapy, including levonorgestrel-releasing intrauterine device or oral progestins.
- Previous pancreatitis, medullary thyroid carcinoma, or multiple endocrine neoplasia type 2.
- Concurrent participation in another interventional pharmacological clinical trial.
- Any condition that, in the investigator's judgment, may compromise participant safety, interfere with protocol compliance, or make participation inappropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SHAPE-ENDO (Strategic Hormonal Approach & Prehabilitation in Endometrial Cancer): An Open-Label, Pilot Randomized Clinical Trial Comparing Standard Immediate Surgery Versus a Multimodal Metabolic Optimization and Prehabilitation Strategy Before Surgery in Patients With Atypical Endometrial Hyperplasia or Low-Risk Endometrioid Endometrial Cancer and BMI ≥40 kg/m²
SHAPE-ENDO is a single-center, open-label, pilot randomized clinical trial conducted at Hospital Universitari de Bellvitge in Barcelona, Spain.
The study will evaluate the feasibility, safety, and acceptability of comparing two treatment strategies in women with atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or low-risk endometrioid endometrial cancer and grade III obesity, defined as BMI ≥40 kg/m².
Read more
Eligible participants will be randomized in a 1:1 ratio to one of two arms. The control arm will undergo standard immediate surgery according to the institutional clinical protocol. The experimental arm will receive the SHAPE-ENDO multimodal pre-surgical optimization strategy before surgery.
The SHAPE-ENDO strategy includes metabolic treatment with semaglutide/Wegovy®, local hormonal therapy with a levonorgestrel-releasing intrauterine device/Mirena® with or without oral medroxyprogesterone acetate/Progevera®, a structured nutritional program, adapted physical exercise, and scheduled oncologic surveillance with clinical evaluation, imaging, and endometrial biopsy with or without hysteroscopy.
The experimental strategy will initially last 28 weeks. In participants with clinical, metabolic, or anthropometric benefit, adequate tolerance, and no evidence of tumor progression, the strategy may be extended up to 54 weeks before surgery.
The primary objective is to evaluate the feasibility, safety, and acceptability of the randomized trial design. Primary feasibility outcomes include recruitment rate, acceptance of randomization, retention, adherence to the assigned intervention, completion of the SHAPE-ENDO strategy, progression during the optimization period, and the proportion of participants in the experimental arm who reach surgery without tumor progression.
Secondary outcomes include perioperative morbidity, histological response in the experimental arm, metabolic and anthropometric changes, quality of life, treatment adherence, safety and tolerability, and exploratory long-term oncologic outcomes including overall survival, recurrence-free survival, and cancer-specific survival.
Read the detailed description
Obesity is a major modifiable risk factor for endometrial cancer and is associated with increased surgical complexity, higher perioperative morbidity, anesthetic risk, and worse functional recovery. Although surgery remains the standard treatment for atypical endometrial hyperplasia and early-stage endometrioid endometrial cancer, patients with grade III obesity may experience a higher risk of perioperative complications.
In operable patients with low-risk endometrial disease and BMI ≥40 kg/m², a structured pre-surgical optimization strategy could improve metabolic and functional status before surgery while maintaining oncologic safety through close surveillance.
The SHAPE-ENDO strategy combines semaglutide-based metabolic optimization, local hormonal therapy with a levonorgestrel-releasing intrauterine device with or without oral progestins, structured nutritional support, adapted physical exercise, and scheduled histologic and radiologic monitoring.
This pilot randomized trial will compare standard immediate surgery with the SHAPE-ENDO multimodal pre-surgical optimization strategy. The aim is not to replace surgery, but to evaluate whether a protocolized and closely monitored optimization window before surgery is feasible, safe, acceptable, and potentially associated with improved perioperative outcomes.
Participants in both arms will undergo long-term clinical and oncologic follow-up for at least 5 years after randomization.
- Conditions
- Endometrial Cancer, Endometrial Cancer Stage I, Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I, Atypical Endometrial Hyperplasia, Endometrial Intraepithelial Neoplasia, Obesity & Overweight
- Being tested
- GLP-1 Receptor Agonist, Levonorgestrel IUD (Lng-IUD), Oral Progestins, Dietetic-Nutritional intervention, Structured Exercise and Prehabilitation Program
- Keywords
- Semaglutide, GLP-1 receptor agonist, levonorgestrel IUD, hormonal therapy, prehabilitation, minimally invasive surgery, robotic surgery, metabolic optimization, endometrial hyperplasia, weight loss intervention, endometrial cancer, endometrial carcinoma, early stage, obesity, cancer, real-world evidence, prospective, ClinicalTrial, wegovy
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia, Obesity, Overweight, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 Receptor AgonistDrug
Also called Semaglutide
Weekly subcutaneous semaglutide/GLP-1 receptor agonist therapy administered according to approved labeling, clinical indication, patient tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. The intervention is used for weight loss and metabolic optimization in participants with severe obesity. Dose, adherence, tolerability, and reasons for dose modification or discontinuation will be recorded prospectively.
Levonorgestrel IUD (Lng-IUD)Device
Also called LNG-IUD
Local hormonal therapy using a 52-mg levonorgestrel-releasing intrauterine system placed at baseline or within 14 days after baseline, with ultrasound confirmation of correct placement. The LNG-IUD is used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment, for local disease control in atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage, low-risk endometrioid endometrial cancer. Tolerability, continuation, adverse events, and local histological response will be recorded prospectively.
Oral ProgestinsDrug
Also called Medroxyprogesterone acetate, Megestrol acetate, Progestin therapy
Systemic hormonal therapy prescribed according to clinical criteria to support local disease control in atypical endometrial hyperplasia or early-stage endometrioid carcinoma. Typical regimens include medroxyprogesterone acetate (400-600 mg/day) or megestrol acetate (160-320 mg/day). Therapy is initiated or escalated when indicated based on tumor burden or suboptimal response to LNG-IUD. Oral progestins may be used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment. Use, dosing, tolerance, and outcomes will be recorded prospectively.
Dietetic-Nutritional interventionBehavioural
Also called Hypocaloric diet program, Nutritional Counseling, Dietary Prehabiilitation
Personalized hypocaloric diet plan supervised by the clinical nutrition team as part of standard obesity and metabolic management. The program includes caloric restriction based on basal metabolic requirements, with the option of very low-calorie diets (VLCD) for 4-6 weeks in selected cases. Follow-up occurs at regular outpatient visits with recording of weight, BMI, waist circumference, and adherence. This intervention is part of routine clinical care and not assigned experimentally; outcomes are recorded prospectively.
Structured Exercise and Prehabilitation ProgramBehavioural
Also called Exercise Prehabilitation, Supervised Physical Activity Program, Combined Aerobic and Strength Training
A structured physical exercise program designed to improve functional capacity, aerobic tolerance, and surgical fitness. Program includes supervised or semi-supervised weekly sessions combining aerobic and strength training, typically 3 sessions per week for 30-45 minutes, adapted to baseline performance. The intervention is part of routine clinical care for patients with obesity undergoing surgical preparation and is not assigned experimentally. Data on adherence, tolerance, and functional outcomes are collected prospectively
Endometrial Biopsy With or Without HysteroscopyProcedure or surgery
Also called Histological Surveillance, Endometrial Sampling, Hysteroscopy
Scheduled histological surveillance performed at baseline and at follow-up intervals (typically 14 and 28-54 weeks) to assess local tumor status, including complete response, stability, or progression. Procedures include outpatient endometrial biopsy with optional hysteroscopy based on clinical indication. These evaluations form part of standard clinical care in patients managed conservatively for atypical endometrial hyperplasia or early-stage endometrioid carcinoma and are not assigned experimentally. Data are recorded prospectively to assess disease evolution and surgical eligibility.
Radiologic Surveillance (MRI and Transvaginal Ultrasound)Procedure or surgery
Also called Pelvic MRI, Transvaginal Ultrasound, Imaging Surveillance
Radiologic evaluation using pelvic MRI and transvaginal ultrasound performed as part of routine clinical care to assess uterine disease, myometrial invasion, adnexal status, and treatment response. Imaging is typically performed at baseline to confirm staging and during follow-up when clinically indicated. These imaging modalities are used per standard clinical guidelines and are not assigned experimentally; results are collected prospectively to evaluate disease stability and surgical planning.
Standar upfront SurgeryProcedure or surgery
Also called Standard Surgery, BSO, Hysterectomy, Upfront Surgery
Standard surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge for atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and a minimally invasive or robotic approach whenever technically possible according to clinical judgment. Surgical approach, operative time, estimated blood loss, conversion to laparotomy, transfusion, hospital stay, intraoperative complications, 30-day postoperative complications, readmission, and sentinel lymph node detection will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Standard Immediate Surgery | Active comparator | Participants randomized to the control arm will undergo standard immediate surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and minimally invasive or robotic approach whenever technically possible according to clinical judgment.
Intervention: Procedure/Surgery - Standard Immediate Surgery Standard surgical management according to institutional practice for atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Perioperative outcomes, surgical approach, conversion to laparotomy, estimated blood loss, operative time, hospital stay, transfusion, sentinel lymph node detection, intraoperative complications, and 30-day postoperative complications graded according to Clavien-Dindo will be recorded. Receives: Procedure: Standar upfront Surgery |
| Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery | Experimental | Participants randomized to the experimental arm will receive the SHAPE-ENDO multimodal pre-surgical optimization strategy before surgery. The strategy includes semaglutide/Wegovy®, levonorgestrel-releasing intrauterine device/Mirena® with or without oral medroxyprogesterone acetate/Progevera®, structured nutritional intervention, adapted physical exercise, and scheduled oncologic surveillance. The strategy will last 28 weeks initially and may be extended up to 54 weeks if there is clinical, metabolic, or anthropometric benefit, adequate tolerance, and no tumor progression.
Intervention: Drug - Semaglutide / Wegovy® Weekly subcutaneous semaglutide administered according to approved labeling, clinical indication, tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. Dose, adherence, tolerability, adverse events, and reasons for dose modification or discontinuation will be recorded.
Intervention: Device - Levonorgestrel-Releasing I Receives: Drug: GLP-1 Receptor Agonist; Device: Levonorgestrel IUD (Lng-IUD); Drug: Oral Progestins; Behavioral: Dietetic-Nutritional intervention; Behavioral: Structured Exercise and Prehabilitation Program; Procedure: Endometrial Biopsy With or Without Hysteroscopy; Procedure: Radiologic Surveillance (MRI and Transvaginal Ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled per month during the active recruitment period. This outcome will assess the feasibility of recruiting eligible participants with atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or low-risk endometrioid endometrial cancer and BMI ≥40 kg/m² into a pilot randomized clinical trial.
Measured: From study opening to end of recruitment, up to 36 months.
Acceptance of Randomization Rate
Proportion of eligible participants who agree to participate in the trial and accept random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy.
Measured: At baseline, before randomization.
Participant Retention Rate
Proportion of randomized participants who complete the planned follow-up required for the main pilot analysis, including surgical treatment and 30-day postoperative assessment, or completion of the assigned intervention period when applicable.
Measured: From randomization to surgery and 30 days postoperatively, up to 14 months.
Adherence to the Assigned Intervention
Proportion of randomized participants who comply with the main procedures planned in their assigned arm. In the control arm, this includes undergoing standard immediate surgery and postoperative follow-up. In the SHAPE-ENDO arm, this includes adherence to the multimodal strategy, scheduled visits, oncologic surveillance, and planned reassessment.
Measured: From randomization to surgery and 30 days postoperatively, up to 14 months.
Completion of the SHAPE-ENDO Multimodal Strategy
Proportion of participants randomized to the SHAPE-ENDO arm who complete the planned multimodal pre-surgical optimization strategy until the week 28 reassessment and, when applicable, until week 54.
Measured: From randomization to week 28 or week 54.
Proportion of SHAPE-ENDO Participants Reaching Surgery Without Tumor Progression
Proportion of participants randomized to the SHAPE-ENDO arm who undergo surgery after the pre-surgical optimization period without histological, radiological, or clinical evidence of tumor progression.
Measured: From randomization to surgery, up to 54 weeks.
Incidence of Serious Adverse Events, Tumor Progression, and Study Discontinuation
Frequency of serious adverse events, tumor progression during the optimization period, and reasons for discontinuation or withdrawal from the study. Adverse events will be recorded prospectively and classified according to CTCAE v5.0 when applicable. These events will be described overall and by randomized arm when applicable.
Measured: From randomization to surgery and 30 days postoperatively, up to 14 months.
Secondary outcomes (27)
Perioperative Morbidity
Proportion of participants with intraoperative complications and/or clinically relevant postoperative complications within 30 days after surgery, compared between the standard immediate surgery arm and the SHAPE-ENDO arm. Postoperative complications will be classified according to the Clavien-Dindo classification, with clinically relevant complications defined as Clavien-Dindo grade ≥II
Measured: At surgery and up to 30 days postoperatively.
Surgical Approach
Proportion of participants undergoing minimally invasive surgery, robotic surgery, conventional laparoscopy, or laparotomy, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Measured: At surgery.
Conversion to Laparotomy
Proportion of participants requiring conversion from minimally invasive surgery to laparotomy, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Measured: At surgery.
Operative Time
Duration of surgery measured in minutes, from skin incision to skin closure, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Measured: At surgery.
Estimated Blood Loss
Estimated intraoperative blood loss measured in milliliters, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Measured: At surgery.
Length of Hospital Stay
Number of days from surgery to hospital discharge, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Measured: From surgery to hospital discharge, up to 30 days.
Need for Blood Transfusion
Proportion of participants requiring perioperative blood transfusion, compared between the standard immediate surgery arm and the SHAPE-ENDO arm
Measured: At surgery and up to 30 days postoperatively.
Sentinel Lymph Node Detection Rate
Proportion of participants in whom sentinel lymph node mapping is successful, including unilateral and bilateral detection rates when sentinel lymph node assessment is performed. Detection rates will be described and compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Measured: At surgery.
Histological Response in the SHAPE-ENDO Arm
Proportion of participants in the SHAPE-ENDO arm with complete response, stable disease, or tumor progression during the pre-surgical optimization period. Complete response is defined as absence of endometrioid carcinoma or atypical hyperplasia in endometrial biopsy. Stable disease is defined as persistence of the lesion without progression in grade or stage. Progression is defined as progression from atypical endometrial hyperplasia/endometrial intraepithelial neoplasia to endometrioid endometrial carcinoma, increase to grade 3, high-risk histology, or extension beyond the uterine corpus.
Measured: Baseline to week 14, week 28, and, if applicable, week 54.
Time to Optimization in the SHAPE-ENDO Arm
Time from randomization to multidisciplinary committee decision indicating that sufficient clinical, metabolic, anthropometric, and oncologic optimization has been achieved to proceed to surgery.
Measured: From randomization to week 28 or week 54
Rate of Surgery After SHAPE-ENDO Optimization
Proportion of participants randomized to the SHAPE-ENDO arm who undergo surgery after the pre-surgical optimization strategy.
Measured: From randomization to surgery, up to 54 weeks.
Change in Glycated Hemoglobin
Change from baseline in glycated hemoglobin, measured as HbA1c percentage using standard clinical laboratory assays. Changes over time will be described within each arm and compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Measured: Baseline to 6 months and baseline to 12 months.
Change in Fasting Plasma Glucose
Change from baseline in fasting plasma glucose concentration, measured in mg/dL using standard laboratory assays. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in Insulinemia and HOMA-IR
Change from baseline in fasting insulin concentration and HOMA-IR, when available. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in FIB-4 Index
Change from baseline in fibrosis-4 index, calculated using age, AST, ALT, and platelet count. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in Lipid Profile
Change from baseline in triglycerides, LDL cholesterol, and HDL cholesterol measured using standard laboratory lipid panel testing. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in Blood Pressure
Change from baseline in systolic and diastolic blood pressure, measured in mmHg during scheduled clinical visits. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in C-Reactive Protein
Change from baseline in serum C-reactive protein concentration, measured in mg/L using standard laboratory assays. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in Body Weight and BMI
Absolute and percentage change from baseline in body weight and body mass index. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in Waist Circumference
Change from baseline in waist circumference, measured in centimeters. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months and baseline to 12 months.
Change in Visceral Adiposity by MRI
Absolute and percentage change from baseline in visceral adiposity measured by pelvic MRI according to the predefined radiologic measurement protocol. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to week 28 and, if applicable, week 54.
Change in Body Composition by Bioelectrical Impedance Analysis
Change from baseline in body composition parameters measured by bioelectrical impedance analysis. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to week 28 and, if applicable, week 54.
Change in Health-Related Quality of Life Score - SF-36
Change from baseline in health-related quality of life assessed using the Short Form-36 Health Survey. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months, 12 months, and during long-term follow-up up to 5 years.
Change in Quality of Life Score - EORTC QLQ-C30
Change from baseline in quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores range from 0 to 100 according to EORTC scoring guidelines. Changes over time will be described within each arm and compared between both randomized arms.
Measured: Baseline to 6 months, 12 months, and during long-term follow-up up to 5 years.
Overall Survival
Time from randomization to death from any cause. Participants alive at the end of follow-up will be censored at the date of last contact.
Measured: From randomization up to 5 years.
Cancer-Specific Survival
Time from randomization to death from endometrial cancer. Participants alive or deceased from causes unrelated to endometrial cancer will be censored according to the statistical analysis plan.
Measured: From randomization up to 5 years.
Recurrence-Free Survival
Time from randomization to first documented recurrence of endometrial cancer. Recurrence may be defined by histological, radiological, or clinical evidence according to standard follow-up criteria. Participants without recurrence will be censored at the date of last available follow-up.
Measured: From randomization up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, pilot randomized clinical trial with two parallel arms. Eligible participants will be randomized in a 1:1 ratio to standard immediate surgery or to the SHAPE-ENDO multimodal pre-surgical optimization strategy followed by surgery. The pilot trial is designed to evaluate feasibility, safety, acceptability, and preliminary efficacy signals to inform a future confirmatory trial.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Jorge García Fernández, Hospital Universitari de Bellvitge
- Investigators
- Jorge Garcia Fernandez, Principal investigator, Hospital Universitari de BellvitgeLola Marti, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462663
- Sponsor's protocol ID
- SHAPE-ENDO
- Acronym
- SHAPE-ENDO
- Status last verified
- Jun 2026
- First submitted
- 23 Nov 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Concin N, Matias-Guiu X, Cibula D, Colombo N, Creutzberg CL, Ledermann J, Mirza MR, Vergote I, Abu-Rustum NR, Bosse T, Chargari C, Espenel S, Fagotti A, Fotopoulou C, Gatius S, Gonzalez-Martin A, Lax S, Levy B, Lorusso D, Macchia G, Marth C, Morice P, Oaknin A, Raspollini MR, Schwameis R, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Planchamp F, Nout RA. ESGO-ESTRO-ESP guidelines for the management of patients with endometrial carcinoma: update 2025. Lancet Oncol. 2025 Aug;26(8):e423-e435. doi: 10.1016/S1470-2045(25)00167-6.
PubMed 40744042Iavazzo C, Gkegkes ID. Conservative management of patients with endometrial intraepithelial neoplasia (EIN): Factors that could affect response and pregnancy rates. Turk J Med Sci. 2022 Jun;52(3):870. doi: 10.55730/1300-0144.5384. Epub 2022 Jun 16. No abstract available.
PubMed 36326317Cui J, Zhao YC, She LZ, Wang TJ. Comparative effects of progestin-based combination therapy for endometrial cancer or atypical endometrial hyperplasia: a systematic review and network meta-analysis. Front Oncol. 2024 May 3;14:1391546. doi: 10.3389/fonc.2024.1391546. eCollection 2024.
PubMed 38764577Laurelli G, Falcone F, Gallo MS, Scala F, Losito S, Granata V, Cascella M, Greggi S. Long-Term Oncologic and Reproductive Outcomes in Young Women With Early Endometrial Cancer Conservatively Treated: A Prospective Study and Literature Update. Int J Gynecol Cancer. 2016 Nov;26(9):1650-1657. doi: 10.1097/IGC.0000000000000825.
PubMed 27654262Fan Z, Li H, Hu R, Liu Y, Liu X, Gu L. Fertility-Preserving Treatment in Young Women With Grade 1 Presumed Stage IA Endometrial Adenocarcinoma: A Meta-Analysis. Int J Gynecol Cancer. 2018 Feb;28(2):385-393. doi: 10.1097/IGC.0000000000001164.
PubMed 29266019Marnach ML, Butler KA, Henry MR, Hutz CE, Langstraat CL, Lohse CM, Casey PM. Oral Progestogens Versus Levonorgestrel-Releasing Intrauterine System for Treatment of Endometrial Intraepithelial Neoplasia<sup/> J Womens Health (Larchmt). 2017 Apr;26(4):368-373. doi: 10.1089/jwh.2016.5774. Epub 2016 Nov 30.
PubMed 27901412Bourou MZ, Matsas A, Valsamakis G, Vlahos N, Panoskaltsis T. The Potential Role of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists as a Type of Conservative Treatment of Endometrial Cancer in Women of Reproductive Age: A Review of the Literature and a Call for Study. Cureus. 2024 Sep 18;16(9):e69678. doi: 10.7759/cureus.69678. eCollection 2024 Sep.
PubMed 39429275Toliver JC, Divino V, Ng CD, Wang J. Real-World Weight Loss Among Patients Initiating Semaglutide 2.4 mg and Enrolled in WeGoTogether, a Digital Self-Support Application. Adv Ther. 2025 Oct;42(10):5010-5022. doi: 10.1007/s12325-025-03325-1. Epub 2025 Aug 6.
PubMed 40768192Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.
PubMed 36216945Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.
PubMed 33755728Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
PubMed 33667417von Gruenigen VE, Tian C, Frasure H, Waggoner S, Keys H, Barakat RR. Treatment effects, disease recurrence, and survival in obese women with early endometrial carcinoma : a Gynecologic Oncology Group study. Cancer. 2006 Dec 15;107(12):2786-91. doi: 10.1002/cncr.22351.
PubMed 17096437Vargiu V, Rosati A, Capozzi VA, Sozzi G, Gioe A, Berretta R, Chiantera V, Scambia G, Fanfani F, Cosentino F. Impact of Obesity on Sentinel Lymph Node Mapping in Patients with apparent Early-Stage Endometrial Cancer: The ObeLyX study. Gynecol Oncol. 2022 May;165(2):215-222. doi: 10.1016/j.ygyno.2022.03.003. Epub 2022 Mar 18.
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