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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID03438474

Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence

Led by Philipps University Marburg · Updated on 2024-11-25

640

Participants Needed

61

Research Sites

52 weeks

Total Duration

On this page

Sponsors

P

Philipps University Marburg

Lead Sponsor

G

German Cancer Aid

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.

CONDITIONS

Brief Title

Endometrial Cancer Lymphadenectomy Trial

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed endometrial cancer of clinical stages T1b and T2 (all histological types) or stage T1a G3 type 1 or type 2 tumors or carcinosarcoma
  • No prior surgery related to endometrial cancer, or surgery within 8 weeks after hysterectomy without lymphadenectomy
  • No bulky lymph nodes present
  • Performance status ECOG 0 or 1
  • Age between 18 and 75 years
  • Provided written informed consent
  • Adequate compliance expected
Not Eligible

You will not qualify if you...

  • Stage pT1a, G1 or G2 tumors of type 1 histology
  • Sarcomas except carcinosarcoma
  • Endometrial cancer stages III or IV except microscopic lymph node metastases
  • Evidence of extrauterine disease by visual inspection
  • Recurrent endometrial cancer
  • Previous chemo-, radio-, or endocrine therapy for endometrial cancer
  • Any disease preventing surgery or chemotherapy
  • Medical history with excessive peri-operative risk
  • Current medication with significant surgical risk (e.g., anticoagulants)
  • Known disorders or circumstances compromising trial participation or follow-up
  • Second malignancies affecting prognosis or treatment
  • Known HIV infection or AIDS
  • Participation in other clinical trials unless allowed by steering committee

Research Team

P

Philipp Harter, Professor MD

G

Günter Emons, Professor MD

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