Clinical trial · Interventional
De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer
De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT
- 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
- interventionNames
- Radiation: Intensity modulated radiation therapy
Primary outcomes (2)
- 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 (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available