RECRUITING

Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).

Official Title

RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer

Quick Facts

Study Start:2021-01-15

Study Completion:2025-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04683653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of primary cervical cancer or uterine cancer of any histology * Age ≥ 18 years. * Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO). * Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively. * Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable. * Eastern Cooperative Oncology Group (ECOG) PS≤ 2 * Able to provide informed consent and willingness to sign an approved consent form	* Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer. * Concurrent (or other) chemotherapy occurring at the time of study. * Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment. * History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis. * Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation. * Recommendation to undergo para-aortic nodal irradiation.

Inclusion Criteria

Exclusion Criteria

* Diagnosis of primary cervical cancer or uterine cancer of any histology
* Age ≥ 18 years.
* Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO).
* Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
* Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
* Eastern Cooperative Oncology Group (ECOG) PS≤ 2
* Able to provide informed consent and willingness to sign an approved consent form

* Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
* Concurrent (or other) chemotherapy occurring at the time of study.
* Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment.
* History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis.
* Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
* Recommendation to undergo para-aortic nodal irradiation.

Contacts and Locations

Study Contact

Christina Son, MD

CONTACT

773-702-6870

cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Christina Son, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Illinois at Chicago (UIC)

Chicago, Illinois, 60612

United States

University of Chicago

Chicago, Illinois, 60637

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Chicago

Christina Son, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-15

Study Completion Date2025-05-22

Study Record Updates

Study Start Date2021-01-15

Study Completion Date2025-05-22

Terms related to this study

Additional Relevant MeSH Terms

Endometrial Cancer