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

The Washington University

Status and phase: Active, not recruiting; Phase 1

Conditions: Endometrial Cancer

Treatments: Radiation: Intensity modulated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04386993

202004237

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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, 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

IMRT

Experimental group

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

Treatment:

Radiation: Intensity modulated radiation therapy