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Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hypofractionated WPRT

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

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

Inclusion Criteria:

Patients with histologically confirmed stage I, II, or III endometrial cancer who require pelvic radiation as determined by their treating radiation oncologist and/or gynecologic oncologist. Patients may also be identified through the Gynecologic Oncology Multidisciplinary Tumor Board. The decision to include Stage I patients will be based on risk factors for recurrence including tumor grade, extent of myometrial invasion, presence of lymphovascular space invasion, and histology (endometrioid, papillary serous, clear cell, carcinosarcoma). Stage I patients may include those who are ineligible for vaginal cuff brachytherapy due to patient anatomy or those who are at higher risk for pelvic nodal recurrence and pelvic external beam radiotherapy is preferred over vaginal cuff brachytherapy.
Age ≥18 years.
ECOG performance status ≤2 (Karnofsky ≥60%).
Patients must have undergone total hysterectomy and bilateral salpingo-oophorectomy with or without pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node (SLN) dissection.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients with an Inflammatory Bowel Disease diagnosis, regardless of disease activity.
Patients with current, active disease involving periaortic node(s). This is based on histologically positive para-aortic node(s) removed at time of surgery.
Patients with gross residual disease following surgical resection. Final pathologic margins must be negative (no tumor on ink). This may also be determined clinically by the gynecologic oncologist at time of surgery or post-operative imaging if applicable. Post-operative imaging is not required at time of surgery.
Patients who have ever had pelvic radiotherapy prior to entering the study.
Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
Patients with uncontrolled intercurrent illness.
Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Sites / Locations

University of Cincinnati Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated Whole-Pelvis Radiotherapy

Arm Description

Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx

Outcomes

Primary Outcome Measures

Safety profile of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer using CTCAE version 5.0 and Patient Reported Outcome-CTCAE.

Toxicity profile will be determined by assessment of acute gastrointestinal and genitourinary toxicity during WPRT and 3 months post-radiation using CTCAE version 5.0 and Patient Reported Outcome-CTCAE (PRO-CTCAE). Dose-limiting toxicity (DLT) will be defined as any acute ≥ grade 3 gastrointestinal or genitourinary per CTCAE or a score of ≥4 on the 5-point scale per PRO-CTCAE.

Maximum tolerated dose per fraction (MTDF) of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer through CTCAE data and gastrointestinal PRO-CTCAE data.

Determination of the MTDF will rely on toxicity data, specifically combined gastrointestinal and genitourinary CTCAE data and gastrointestinal PRO-CTCAE data. MTDF should not exceed >20% of patients having a DLT per CTCAE or >55% of patients having a dose-limiting GI toxicity per PRO-CTCAE. Further details in study design.

Secondary Outcome Measures

Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.

Quality of life data will be obtained for exploratory analysis only.

Patient compliance with hypofractionated WPRT, as defined by how many patients are able to complete WPRT without a break in treatment.

Patient compliance with radiotherapy will be recorded and used for exploratory analysis only.

Full Information

NCT ID

NCT04458402

First Posted

July 1, 2020

Last Updated

February 9, 2021

Sponsor

Teresa Meier

1. Study Identification

Unique Protocol Identification Number

NCT04458402

Brief Title

Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer

Official Title

Phase I Study of Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 4, 2021 (Actual)

Primary Completion Date

February 4, 2024 (Anticipated)

Study Completion Date

July 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Teresa Meier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Studying adjuvant hypofractionated whole pelvis radiation therapy in Endometrial Cancer.

Detailed Description

This is a Phase I study evaluating the safety of adjuvant hypofractionated whole pelvis radiation therapy (WPRT) in endometrial cancer. The primary objective of the study is to determine the maximum tolerated dose per fraction (MTDF), defined by acceptable acute clinician-reported GI and GU toxicity and patient-reported GI toxicity, of WPRT from among the two study dose levels. Acute GI and GU toxicity will be assessed according to both the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0, and Patient Reported Outcome-CTCAE (PRO-CTCAE). Clinician-reported dose-limiting toxicity (C-DLT) is a binary outcome (yes/no), defined as an acute grade 3 or higher GI or GU per CTCAE, occurring within three months of completing WPRT. Patient-reported DLT (P-DLT) is a binary outcome, defined by a GI toxicity with a score of ≥4 on the 5-point scale per PRO-CTCAE, occurring within three months of completing WPRT. The MTDF is defined as the minimum of the dose with a C-DLT rate closest to the clinician-reported target C-DLT rate of 20% and the dose with a P-DLT rate closest to the patient-reported target P-DLT rate of 55%. Toxicity results of NRG-RTOG 1203- A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer- were used to define the acceptable percentage of DLTs. The study will accrue participants in cohorts of size 3. The starting dose level will be dose level 1 (41.25 Gy in 15 fx).

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

Sequential Assignment

Model Description

Dose allocation will be based upon a Bayesian continual reassessment method that incorporates patient-reported outcomes (PRO-CRM17), which uses separate models for the probability of C-DLT and the probability of P-DLT, as well as the accumulated C-DLT and P-DLT data at each dose level, to sequentially allocate each new patient cohort.

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated Whole-Pelvis Radiotherapy

Arm Type

Experimental

Arm Description

Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated WPRT

Intervention Description

Cohort 1: 41.25 Gy in 15 fx Cohort 1: 38 Gy in 10 fx

Primary Outcome Measure Information:

Title

Safety profile of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer using CTCAE version 5.0 and Patient Reported Outcome-CTCAE.

Description

Time Frame

3 months

Title

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.

Description

Quality of life data will be obtained for exploratory analysis only.

Time Frame

3 months

Title

Patient compliance with hypofractionated WPRT, as defined by how many patients are able to complete WPRT without a break in treatment.

Description

Patient compliance with radiotherapy will be recorded and used for exploratory analysis only.

Time Frame

3 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically confirmed stage I, II, or III endometrial cancer who require pelvic radiation as determined by their treating radiation oncologist and/or gynecologic oncologist. Patients may also be identified through the Gynecologic Oncology Multidisciplinary Tumor Board. The decision to include Stage I patients will be based on risk factors for recurrence including tumor grade, extent of myometrial invasion, presence of lymphovascular space invasion, and histology (endometrioid, papillary serous, clear cell, carcinosarcoma). Stage I patients may include those who are ineligible for vaginal cuff brachytherapy due to patient anatomy or those who are at higher risk for pelvic nodal recurrence and pelvic external beam radiotherapy is preferred over vaginal cuff brachytherapy. Age ≥18 years. ECOG performance status ≤2 (Karnofsky ≥60%). Patients must have undergone total hysterectomy and bilateral salpingo-oophorectomy with or without pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node (SLN) dissection. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients with an Inflammatory Bowel Disease diagnosis, regardless of disease activity. Patients with current, active disease involving periaortic node(s). This is based on histologically positive para-aortic node(s) removed at time of surgery. Patients with gross residual disease following surgical resection. Final pathologic margins must be negative (no tumor on ink). This may also be determined clinically by the gynecologic oncologist at time of surgery or post-operative imaging if applicable. Post-operative imaging is not required at time of surgery. Patients who have ever had pelvic radiotherapy prior to entering the study. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI. Patients with uncontrolled intercurrent illness. Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Central Contact Person:

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

UCCC Clinical Trials Office

Phone

513-584-7698

cancer@uchealth.com

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

Teresa Meier, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teresa Meier, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

UCCC CTO

Phone

513-584-7698

cancer@uchealth.com

First Name & Middle Initial & Last Name & Degree

Teresa Meier, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer

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