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Clinical trials landscape in uterine adenosarcoma

TL;DR — No adenosarcoma-only randomised trial or adenosarcoma-specific randomised outcome was found. Direct ClinicalTrials.gov keyword searches on 2026-09-01 still returned five records for “uterine adenosarcoma” and seven for “adenosarcoma,” but those searches are incomplete: a record-level scan of all 287 studies returned for query.cond=uterine sarcoma found additional protocols whose eligibility text names adenosarcoma. These include a mixed-histology phase 3 adjuvant chemoradiotherapy study (NCT00162721; status unknown, estimated n=270, no posted results), EORTC 62113 cabozantinib maintenance (NCT01979393; completed, actual n=58), terminated phase 2 vorinostat (NCT03509207; actual n=3) and immunochemotherapy (NCT05481645; actual n=71) studies, completed FUCHSia fulvestrant (NCT03926936; actual n=17), and recruiting elacestrant (NCT07467772; estimated n=30). None reports an adenosarcoma-specific efficacy estimate.

How this page was built

All trial records below were retrieved from ClinicalTrials.gov v2 during the independent audit on 2026-09-01. Counts:

Query Studies returned
query.term=uterine adenosarcoma 5
query.term=adenosarcoma 7
query.cond=uterine sarcoma (countTotal) 287 (almost all not adenosarcoma)

Because keyword results missed eligibility-only mentions, all 287 uterine sarcoma records were fetched and searched for adenosarcoma; nine contained the string somewhere in the record. Six interventional records explicitly name adenosarcoma in eligibility. The remaining hits were non-specific uterine-sarcoma or imaging studies, or records in which the term appears outside an eligible named cohort. This record-level scan, rather than the five-hit keyword query, is the basis of the absence statements below.

The five direct “uterine adenosarcoma” keyword hits:

NCT Status Phase What it actually is
NCT03926936 COMPLETED 2 FUCHSia: fulvestrant in ER+ low-grade gyn cancers, including low-grade adenosarcoma without SO
NCT07467772 RECRUITING 2 Elacestrant in ER+ uterine sarcomas, including adenosarcoma
NCT02834013 ACTIVE_NOT_RECRUITING 2 DART: nivo/ipi in rare tumours; adenosarcoma not a named histologic cohort
NCT02020707 COMPLETED 1 Nab-paclitaxel + bevacizumab in melanoma or epithelial gyn cancers; “cervical adenosarcoma” is a condition tag, but eligibility lists epithelial cervical histologies and does not permit adenosarcoma
NCT07394413 NOT_YET_RECRUITING NA (observational) Fertility-preserving surgery in cervical adenocarcinomas; title/condition string includes “Cervical Adenosarcoma” as a likely mis-tag

Two additional “adenosarcoma” keyword hits (NCT00413322, NCT00413075) are PXD101 (belinostat) solid-tumour phase 1 studies from the mid-2000s; neither names adenosarcoma in eligibility.

Interventional records that name adenosarcoma in eligibility

Mixed-histology phase 3 adjuvant chemoradiotherapy — NCT00162721 (status unknown)

Randomised, open-label phase 3 registration comparing the addition of doxorubicin/ifosfamide/cisplatin polychemotherapy to adjuvant radiotherapy in fully resected, non-metastatic uterine sarcomas. Eligibility explicitly includes leiomyosarcoma, adenosarcoma, carcinosarcoma, and high-grade endometrial stromal sarcoma. The record estimates 270 participants, started in 2001, has not been verified since 2007, has status UNKNOWN, and has no posted results. It proves that a randomised mixed-histology adjuvant protocol was registered; it does not provide evidence that the planned sample accrued or that chemotherapy improved survival in adenosarcoma.

FUCHSia — NCT03926936 (completed)

Phase 2, open-label, fulvestrant in women with ER-positive recurrent/metastatic low-grade gynecologic cancers. Conditions listed: endometrial stromal sarcoma, adenosarcoma of uterus, leiomyosarcoma uterus, endometrial cancer, sex cord stromal tumour, serous ovarian tumour. Actual enrolment 17. Eligibility for the sarcoma arm: “Recurrent or metastatic low grade uterine sarcomas (low grade endometrial stromal sarcoma, low grade adenosarcoma without sarcomatous overgrowth and low grade leiomyosarcoma)”; ER-positive by Allred; at least and maximum of 1 prior hormonal therapy with ≥3 months of response; measurable disease; postmenopausal. Primary endpoint: RECIST 1.1 response rate at week 24. Completed 2022-12-27; hasResults false on ClinicalTrials.gov as of this query. No PubMed-indexed primary results paper was returned by searches in this session.

Elacestrant — NCT07467772 (recruiting)

Phase 2, ER-positive advanced uterine sarcomas not amenable to surgery. Subtypes: uLMS, ESS, uterine adenosarcoma, uterine PEComa. ER moderate-to-strong in ≥75% of tumour cells. Estimated enrolment 30. Start date recorded as 2026-03-25. This is the only recruiting interventional study retrieved whose eligibility explicitly lists uterine adenosarcoma.

DART / SWOG S1609 — NCT02834013 (active, not recruiting)

Phase 2 nivolumab + ipilimumab in rare tumours, actual enrolment 798. Eligibility is by named histologic cohorts or (historically) a “not otherwise categorized” rare-tumour cohort closed 2019-03-15. The eligibility text retrieved this session does not contain the strings “adenosarcoma” or “uterine sarcoma.” Adenosarcoma would have been eligible only if matched to a listed rare-tumour cohort or the closed NOC cohort. Do not list DART as an adenosarcoma trial.

EORTC 62113 cabozantinib maintenance — NCT01979393 (protocol paper)

Randomised double-blind phase 2 of cabozantinib vs placebo maintenance after doxorubicin ± ifosfamide in high-grade uterine sarcoma. Inclusion histologies: high-grade undifferentiated uterine sarcoma, high-grade ESS, high-grade leiomyosarcoma, high-grade adenosarcoma, FIGO II/III–IV, in SD/PR/CR after chemotherapy. The protocol paper reported 83 registered and 35 randomised while recruitment was ongoing (Ray-Coquard 2020, PMID 32546554); the current registry record reports 58 actual participants and completed status. This is a high-grade uterine-sarcoma trial that included adenosarcoma, not an adenosarcoma trial. No PubMed-indexed adenosarcoma-specific outcome was retrieved in the 2026-09-01 search.

Vorinostat — NCT03509207 (terminated)

Single-group phase 2 vorinostat for refractory, HDAC-positive uterine sarcomas, with adenosarcoma explicitly eligible. The study terminated for very slow recruitment and access to study drug after 3 participants; only one reached the first endpoint, so the posted results state that statistical evaluation was impossible. The registry does not identify participant histologies, so it cannot be assumed that an adenosarcoma patient was treated.

TQB2450 plus chemotherapy ± anlotinib — NCT05481645 (terminated)

Randomised phase 2 in advanced endometrial cancer or uterine sarcoma. The uterine-sarcoma group explicitly allowed adenosarcoma with sarcomatous overgrowth and ER/PR-positive adenosarcoma without overgrowth after anti-estrogen treatment failure. It terminated at 71 actual participants at sponsor request, not for safety or efficacy, and has no posted results. The record does not report an adenosarcoma subset.

NCT02020707 (completed phase 1; false-positive condition tag)

Nab-paclitaxel + bevacizumab; the conditions list includes “cervical adenosarcoma,” but the eligibility text permits epithelial cervical cancers (squamous, adenocarcinoma, and adenosquamous) and does not list adenosarcoma. It is neither a uterine-corpus nor a cervical adenosarcoma study.

What does not exist (verified 2026-09-01)

  • No adenosarcoma-only interventional trial or randomised trial.
  • No reported adenosarcoma-specific randomised outcome. NCT00162721 is a mixed-histology phase 3 registration with unknown status and no posted results.
  • No adenosarcoma-specific radiotherapy-versus-no-radiotherapy randomised outcome.
  • No PI3K/AKT/mTOR inhibitor trial restricted to or stratified for adenosarcoma, despite ~70% pathway alteration (Howitt 2015, PMID 25231023).
  • No MDM2-amplified, BAP1-deleted, or TERT-altered histology-specific trial.

Friedlander 2014 stated there had not been clinical trials in Müllerian adenosarcoma (Friedlander 2014, PMID 25341585). The registry audit shows that this wording was too broad even then: NCT00162721 had been registered years earlier, although its status and conduct remain unresolved. The defensible current statement is narrower—no dedicated trial and no reported adenosarcoma-specific randomised result.

Why the trial landscape looks like this

PubMed holds 258 records for uterine adenosarcoma in total (live E-utilities search 2026-09-01). Single-institution series top out around 100–165 patients (Carroll 2014, PMID 25449308; Nathenson 2018, PMID 30044322). The registry history shows that mixed-histology designs are feasible, but the old phase 3 record has no posted result and the audit found no corresponding adenosarcoma-specific publication; the small baskets cannot yield a usable histology-specific endpoint unless outcomes are reported by histology.

Open questions

  • Did any of the 17 FUCHSia patients have adenosarcoma, and did they respond? Completed 2022; results not PubMed-indexed as of this session.
  • Will NCT07467772 accrue enough adenosarcoma (versus LMS/ESS/PEComa) to report a subtype outcome?
  • Is a registry-randomised adjuvant study in stage I SO feasible through GCIG/EURACAN? It is the trial the Carroll signal asks for (Carroll 2014, PMID 25449308).

References

  1. Friedlander ML, et al. GCIG consensus review for mullerian adenosarcoma of the female genital tract. Int J Gynecol Cancer. 2014;24:S78-82. PMID 25341585
  2. Ray-Coquard I, et al. A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma (EORTC62113). Int J Gynecol Cancer. 2020;30:1633-1637. PMID 32546554
  3. Howitt BE, et al. Targeted genomic analysis of Müllerian adenosarcoma. J Pathol. 2015;235:37-49. PMID 25231023
  4. Carroll A, et al. Uterine adenosarcoma: an analysis on management, outcomes, and risk factors for recurrence. Gynecol Oncol. 2014;135:455-61. PMID 25449308
  5. Nathenson MJ, et al. The Importance of Lymphovascular Invasion in Uterine Adenosarcomas. Int J Gynecol Cancer. 2018;28:1297-1310. PMID 30044322