Clinical trial NCT04386993: De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer
Official title: De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Endometrial Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events
timeFrame: From start of radiation through Day 90
measure: Incidence of late hematologic, gastrointestinal, and genitourinary adverse events
timeFrame: From Day 91 through month 12
Secondary outcomes:
measure: Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE
timeFrame: Baseline, 2 weeks, and 3 months post-completion of radiation
measure: Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26
timeFrame: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
measure: Change in quality of life as measured by FACT-En
timeFrame: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
measure: Locoregional control
timeFrame: Up to 12 months post-completion of radiation
measure: Distant control
timeFrame: Up to 12 months post-completion of radiation
measure: Disease-free survival
timeFrame: Up to 12 months post-completion of radiation
measure: Overall survival
timeFrame: Up to 12 months post-completion of radiation
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jessika Contreras, M.D.
role: PRINCIPAL_INVESTIGATOR
References: