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De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)

Primary Purpose

Endometrial Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intensity modulated radiation therapy

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, or carcinosarcoma histology.
Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.
At least 18 years of age.
ECOG performance status ≤ 2
Minimal bone marrow and organ function as defined below:
- Leukocytes ≥ 1,000 cumm
- Absolute neutrophil count ≥ 500 cumm
- Platelets ≥ 50,000 cumm
- Hemoglobin ≥ 7g/dL
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

Prior radiation to the pelvis.
Currently receiving any investigational agents.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.
Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Sites / Locations

Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT

Arm Description

-Five 5-Gy fractions of IMRT will be given to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy. -*Brachytherapy boost (at the discretion of the PI) within 2 weeks of radiation therapy completion. Once or twice weekly for three weeks

Outcomes

Primary Outcome Measures

Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events

Incidence of late hematologic, gastrointestinal, and genitourinary adverse events

Secondary Outcome Measures

Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE

PRO-CTCAE responses are scored from 0 to 4 with 0=Never/Not at all/None and 4=Frequently/Very Much/Very Severe/Almost Constantly Scores for each attribute (frequency, severity and/or interference) will be presented descriptively

Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26

Bladder has 7 questions and bowel has 9 questions The response for each item is standardized to a 0 to 100 scale The standardized values will be averaged for all items within a group to create the summary or subscale score.

Change in quality of life as measured by FACT-En

Questionnaire asking questions about physical well-being, social/family well-being, emotional well-being, functional well-being, and other additional concerns. Answers range from 0 = not at all to 4 = very much. Questions are phrased so that higher numbers indicate a better health state, Scoring is performed through a simple sum of item scores. Each subscale is scored, and a total score is obtained by adding each of the subscale scores.

Locoregional control

-Locoregional recurrence is defined as histologic or radiographic evidence of cancer in the previously resected site or regional lymph nodes included in the radiated field.

Distant control

-Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.

Disease-free survival

-Disease-free survival is defined as survival with no evidence of disease recurrence or death

Overall survival

-Number of participants alive at the time of completion of follow-up

Full Information

NCT ID

NCT04386993

First Posted

May 8, 2020

Last Updated

May 17, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04386993

Brief Title

De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer

Acronym

DeCRESCEndo

Official Title

De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 7, 2020 (Actual)

Primary Completion Date

August 31, 2025 (Anticipated)

Study Completion Date

August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate < 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMRT

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Intensity modulated radiation therapy

Other Intervention Name(s)

IMRT

Intervention Description

Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).

Primary Outcome Measure Information:

Title

Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events

Time Frame

From start of radiation through Day 90

Title

Incidence of late hematologic, gastrointestinal, and genitourinary adverse events

Time Frame

From Day 91 through month 12

Secondary Outcome Measure Information:

Title

Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE

Description

Time Frame

Baseline, 2 weeks, and 3 months post-completion of radiation

Title

Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26

Description

Time Frame

Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation

Title

Change in quality of life as measured by FACT-En

Description

Time Frame

Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation

Title

Locoregional control

Description

-Locoregional recurrence is defined as histologic or radiographic evidence of cancer in the previously resected site or regional lymph nodes included in the radiated field.

Time Frame

Up to 12 months post-completion of radiation

Title

Distant control

Description

-Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.

Time Frame

Up to 12 months post-completion of radiation

Title

Disease-free survival

Description

-Disease-free survival is defined as survival with no evidence of disease recurrence or death

Time Frame

Up to 12 months post-completion of radiation

Title

Overall survival

Description

-Number of participants alive at the time of completion of follow-up

Time Frame

Up to 12 months post-completion of radiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, de-differentiated, or carcinosarcoma histology. Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment. At least 18 years of age. ECOG performance status ≤ 2 Minimal bone marrow and organ function as defined below: Leukocytes ≥ 1,000 cumm Absolute neutrophil count ≥ 500 cumm Platelets ≥ 50,000 cumm Hemoglobin ≥ 7g/dL Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: Prior radiation to the pelvis. Currently receiving any investigational agents. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease. Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessika Contreras, M.D.

Phone

314-747-7236

jcontreras@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessika Contreras, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessika Contreras, M.D.

Phone

314-747-7236

jcontreras@wustl.edu

First Name & Middle Initial & Last Name & Degree

Jessika Contreras, M.D.

First Name & Middle Initial & Last Name & Degree

Stephanie Markovina, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Matthew Powell, M.D.

First Name & Middle Initial & Last Name & Degree

Yi Huang, M.S.

First Name & Middle Initial & Last Name & Degree

Julie Schwarz, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Andrea Hagemann, M.D.

First Name & Middle Initial & Last Name & Degree

Lindsay Kuroki, M.D.

First Name & Middle Initial & Last Name & Degree

L. Stewart Massad, M.D.

First Name & Middle Initial & Last Name & Degree

Carolyn McCourt, M.D.

First Name & Middle Initial & Last Name & Degree

David Mutch, M.D.

First Name & Middle Initial & Last Name & Degree

Premal Thaker, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) for individual participant data meta-analysis by investigators whose proposed use of data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD Sharing Time Frame

Proposals may be submitted up to 36 months following article publication.

IPD Sharing Access Criteria

Please contact Dr. Alexander Lin at alexanderlin@wustl.edu

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer

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