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Clinical trials landscape in uterine adenosarcoma

TL;DR — No adenosarcoma-only randomised trial or reported adenosarcoma-specific randomised outcome was identified in the sources searched through 2026-10-24. ClinicalTrials.gov keyword searches returned five “uterine adenosarcoma” and seven “adenosarcoma” records; scanning all 292 uterine-sarcoma records found the same nine string matches as on 2026-10-17. FUCHSia provides one histology-identified partial response to fulvestrant in low-grade adenosarcoma without SO, not a reliable response-rate estimate (Trozzi 2024, PMID 38724237; NCT03926936). EORTC 62113 now has mixed-histology results in EudraCT, despite no results posted on ClinicalTrials.gov (NCT01979393); its reported baseline tables do not identify an adenosarcoma subset. Elacestrant remains recruiting (NCT07467772).

How this page was built

All 14 NCT IDs cited anywhere in this condition were retrieved from ClinicalTrials.gov v2 on 2026-10-24 (the 12 tracked in the previous manifest plus two background-only observational records). The 12 previously tracked records have unchanged status, enrolment, results flag and last-update date. Counts:

Query Studies returned
query.term=uterine adenosarcoma 5
query.term=adenosarcoma 7
query.cond=uterine sarcoma (countTotal) 292 (almost all not adenosarcoma)

All 292 uterine sarcoma records were fetched and searched in full for adenosarcoma; the same nine records as on 2026-10-17 contained the string (NCT03926936, NCT01979393, NCT05481645, NCT03509207, NCT02834013, NCT00162721, NCT07467772, NCT04123158, NCT05881967). Six interventional records explicitly name adenosarcoma in eligibility; DART (NCT02834013) does not. NCT04123158 and NCT05881967 mention it only in observational background text. The one-record increase in the broad condition search did not add a string match. EudraCT search adenosarcoma returned five protocols, including FUCHSia (2017-005018-76) and EORTC 62113 (2013-000762-11), plus three paediatric protocols of other scope. ISRCTN returned a cookie/JavaScript holding page, so no absence is inferred from it. CENTRAL was not searchable.

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. ClinicalTrials.gov 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 2026-10-24.

The full paper, recovered from the EudraCT publication attachment on 2026-10-24, resolves OQ-12: Table 1 identifies one adenosarcoma among four uterine sarcomas, and the Efficacy section identifies the partial responder as low-grade adenosarcoma without SO. This is one patient in a single-arm phase 2 basket, not a histology-specific efficacy estimate. Table 1 lists the other histologies as two ESS and one unknown, whereas the narrative describes three low-grade ESS; that discrepancy is preserved (Trozzi 2024, PMID 38724237). Full paper via EudraCT (attachment published 2024-06-09; accessed 2026-10-24).

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 (EU registry results available)

Randomised double-blind phase 2 cabozantinib versus placebo maintenance after doxorubicin ± ifosfamide, with high-grade adenosarcoma eligible (protocol: Ray-Coquard 2020, PMID 32546554). ClinicalTrials.gov reports completed status, actual n=58 and hasResults false. The EudraCT final-results record, first published 2026-06-18, instead reports 59 randomised participants (30 cabozantinib, 29 placebo). Its primary endpoint table gives 13 versus 12 patients alive without progression at four months; the pre-specified one-sided Fisher test gives p=0.544. Baseline tables report age, sex and performance status, without histology counts, so these are mixed-histology results and cannot establish an adenosarcoma treatment effect. The 58-versus-59 registry discrepancy is unresolved (EudraCT — “2013-000762-11 clinical trial results”, https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000762-11/results, accessed 2026-10-24).

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 2026-10-10)

  • 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 262 records for uterine adenosarcoma in total (live E-utilities search 2026-10-24). 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

  • Can the single FUCHSia adenosarcoma response be replicated in a prospectively reported histology-specific cohort (Trozzi 2024, PMID 38724237)?
  • Can the EORTC 62113 investigators reconcile the registry totals and report adenosarcoma enrolment and outcomes separately?
  • 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
  6. Trozzi R, et al. An open-label, single-arm, prospective, multi-center, tandem two-stage designed phase II study to evaluate the efficacy of fulvestrant in women with recurrent/metastatic estrogen receptor-positive gynecological malignancies (FUCHSia study). Int J Gynecol Cancer. 2024;34:1217-1224. PMID 38724237