NCT02773966 is a Phase 3 clinical trial of Kypho-IORT in Metastasis, sponsored by Universitätsmedizin Mannheim.

Who is sponsoring NCT02773966?

NCT02773966 is sponsored by Universitätsmedizin Mannheim.

What drugs are being tested in NCT02773966?

Interventions in NCT02773966: Kypho-IORT, EBRT.

What condition does NCT02773966 study?

NCT02773966 studies Metastasis.

Is NCT02773966 still recruiting?

NCT02773966 is currently terminated. Last updated 22 July 2022.

Last reviewed 2022-07-22 · How we verify

NCT02773966

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Kypho-IORT vs. EBRT in Spinal Metastases

Terminated Phase 3 Last updated 22 July 2022

What this trial tests

Phase 3 trial testing Kypho-IORT in Metastasis in 6 participants. Terminated before completion.

Timeline

12 November 2017

Primary endpoint
6 March 2020

6 March 2020

Quick facts

Lead sponsor	Universitätsmedizin Mannheim
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	12 November 2017
Primary completion	6 March 2020
Estimated completion	6 March 2020
Sites	1 location across Germany

Drugs / interventions tested

Kypho-IORT
EBRT

Conditions studied

Metastasis — all drugs for Metastasis →

Sponsor

Universitätsmedizin Mannheim — full company profile →

Who can join

50 and older, any sex, with Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this randomized phase III study is to test the superiority of Kypho-IORT compared to EBRT with regard of time to pain reduction in patients with painful vertebral metastases. Therefore patients will receive intraoperative radiotherapy (8 Gy with Intrabeam System/Carl Zeiss) during kyphoplasty (Arm A) or external beam radiotherapy with 30 Gy, added in 3 Gy per fraction on a conventional linear accelerator or 8 Gy single dose (only for international study centers, not permitted in Germany) (Arm B).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Long-term outcome after combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) for vertebral tumors.
Bludau F, Winter L, Welzel G, Obertacke U, et al · · 2020 · cited 9× · PMID 33183307 · DOI 10.1186/s13014-020-01715-z
Combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) versus external beam radiotherapy (EBRT) for painful vertebral metastases - a randomized phase III study.
Bludau F, Welzel G, Reis T, Abo-Madyan Y, et al · · 2019 · cited 6× · PMID 31072314 · DOI 10.1186/s12885-019-5666-5
Keynote Address at the American Society of Breast Surgeons 18th Annual Meeting : Current and Future Application of Intraoperative Radiotherapy (IORT) in the Curative and Palliative Treatment of Breast Cancer.
Wenz F. · · 2017 · cited 3× · PMID 28766200 · DOI 10.1245/s10434-017-5942-z

Verify or expand the search:

Other recruiting trials for Metastasis

Currently open trials in the same condition.

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NCT06863272 — A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Re · Phase 1, PHASE2 · recruiting
NCT07040657 — Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometria · NA · recruiting
NCT07154563 — Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Ca · recruiting
NCT06362369 — A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy · Phase 1, PHASE2 · recruiting

Other Universitätsmedizin Mannheim trials

Trials by the same sponsor.

NCT06416319 — Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct) · NA · recruiting
NCT04534998 — Robotic-assisted vs. Open Partial Nephrectomy · Phase 2 · unknown
NCT05575856 — Cardiogenic Shock Registry Mannheim · unknown
NCT04146701 — Metabolomics and Microbiomics in Cardiovascular Diseases · unknown
NCT04533633 — German Epicardial Collateral CTO Registry · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02773966 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitätsmedizin Mannheim
Last refreshed: 22 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02773966.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing