Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Sarcoma

Sarcoma, Endometrial Stromal

Endometrial Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endometrial Stromal Tumors

Soft Tissue Sarcoma

Endometrial Stromal Sarcoma

Patients with POLE-mutated early-stage EC undergo observation on study. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.

Patients with higher-risk POLE-mutated EC undergo observation or EBRT and/or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.

Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.

Clinical Observation

Computed Tomography

External Beam Radiation Therapy

High-Dose-Rate Vaginal Brachytherapy

Magnetic Resonance Imaging

Positron Emission Tomography

Questionnaire Administration

X-Ray Imaging

Matthew A Powell

This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

PRIMARY OBJECTIVE:

I. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status.

SECONDARY OBJECTIVES:

I. Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and distant metastasis at 3 years.

II. Estimate the recurrence-free, endometrial cancer-specific and overall survival.

III. Describe the impact of molecular classification on patient decisional conflict and fear of recurrence.

TERTIARY OBJECTIVES:

I. Evaluate health economic impact of molecular classification-tailored adjuvant therapy on the cost of treating endometrial cancer.

II. Evaluate quality of life. III. Determine if variability in adjuvant treatment given to patients with endometrial cancer is decreased by molecular classification-tailored adjuvant therapy as compared to recent clinical practice data.

IV. To assess if additional molecular parameters can further refine prognosis within POLE-mutated and p53wt/no specific molecular profile (NSMP) endometrial cancer (EC).

OUTLINE: Patients are assigned to 1 of 2 sub-studies.

SUB-STUDY A: Patients are assigned to 1 of 2 cohorts.

COHORT A1: Patients with POLE-mutated early-stage EC undergo observation on study.

COHORT A2: Patients with higher-risk POLE-mutated EC undergo observation or external beam radiation therapy (EBRT) and/or vaginal brachytherapy over 3-5 fractions.

SUB-STUDY B: Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions.

All patients undergo chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans during screening and as clinically indicated throughout the trial.

After completion of study treatment, patients are followed up at 3 and 6 months, then every 6 months for 3 years, and then every year.

Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer

A Phase II Study of Tailored Adjuvant Therapy in Pole-Mutated and p53-Wildtype/NSMP Early-Stage Endometrial Cancer (RAINBO BLUE &Amp; TAPER)

Will include disease recurrence in the vagina, post-operative bed and pelvic lymph nodes. Histological evidence of recurrence in the vagina will be required. For pelvic nodal recurrence, the suspicious lymph node(s) should measure \>= 10 mm in short axis and be confirmed with at least 2 methods (e.g. histological and radiological; or 2 different imaging modalities such as computed tomography and fludeoxyglucose F 18 positron emission tomography or magnetic resonance imaging; or evidence of lymph node growth on 2 imaging exams at least 2 months apart). All recurrences will be reviewed by a central adjudication committee. Distant metastasis and death in absence of pelvic failure will be considered competing risk events in the analysis of this endpoint. Subjects without any of the listed events (i.e. events of interest or competing risks events) are censored at the date of the most recent follow-up examination.

Distant metastasis and death in absence of vaginal failure will be considered competing risk events in the analysis.

All patients who have completed the Fear of Recurrence Inventory are evaluable for fear of recurrence.

National Cancer Institute (NCI)

Canadian Cancer Trials Group

NRG Oncology

Spots Global Cancer Trial Database for stage ii uterine corpus endometrial stromal sarcoma ajcc v8