Randomized phase II/III trial of stereotactic body radiotherapy versus conventional multi-fractional radiotherapy for spine metastases.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004281

Enrollment

Unknown

Registered

2014-02-21

Start date

2014-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal metastasis

Interventions

control group:conventional multi-fractional radiotherapy

research group:stereotactic body radiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Aged 18 years and more; Histologically proven primary malignancy; Histologically or imaging shown spinal metastasis; Be able to lie flat for an extended period of time; Karnofsky performance status score=40; The number of spinal metastases =3; Life expectancy more than half a year(revised Tokuhashi score=9); No mechanically unstable spine or fracture; No previous radiotherapy or radionuclide therapy to the metastatic spinal segment; WBC=2.5×10^9/L, PLT=70.0×10^9/L,Hb =70g/L; Patient consensus.

Exclusion criteria

Exclusion criteria: The spine canal constriction 25% or more; Spine displacement; Epidural compression approaching spinal cord within 3mm; Spine instability may due to a compression fracture; Unsustainable to MRI for any reason; History of connective tissue disease; Pregnant women.

Design outcomes

Primary

Measure	Time frame
Pain Score;OME;	—

Secondary

Measure	Time frame
metastasis tumor size;	—

Countries

China

Contacts

Public ContactZhuang Tingting

Cancer Hospital of Shantou University Medical College

ttz303@21cn.com+86 18902746030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 11, 2026