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Targeted radiation zaps bone tumors in new trial

NCT ID NCT02880319

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tests a high-precision radiation therapy called SBRT for people whose cancer has spread to the spine or other bones. The goal is to see if SBRT can control tumor growth at the treated spots for at least 6 months. About 150 adults with solid tumors (not blood cancers) and up to 3 affected vertebrae are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stereotactic body radiation therapy (SBRT)
What this could lead to
If successful, this could provide a non-surgical option to control cancer that has spread to bones, potentially improving local tumor control and quality of life.
What could go wrong
This is a mid-stage trial with only 150 participants, so results may not apply to all patients. Radiation can cause side effects like pain or fracture, and the treatment may not prevent cancer from spreading elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

150 people

The number who actually took part.

Started

Nov 2016

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Both cohorts: --≥18 years of age * ECOG performance status ≤2 * Pathologically proven metastatic solid tumor (non-hematologic malignancy) of the bone (spine or non-spine bone) * Bony metastatic lesions must be ≤6 cm in maximum dimension and evaluable on either a CT or MRI scan; metastatic lesions in the spine must involve ≤3 contiguous vertebral bodies * No other active malignancy within the past 2 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix * Ability to understand and the willingness to sign a written informed consent document * Surgery to the lesion in question is allowed if size criteria outlined above are met * Not currently pregnant or breast feeding * Cohort 1: Oligometastatic state * Oligometastatic state is defined by ≤ 3 active sites of disease, including the primary site * Agreement of both the Chow et al.15 and TEACHH16 models, indicating a median life expectancy of \>3 months * Among patients with multiple sites of metastatic disease, the other sites that will not be treated on this protocol have either been previously treated or are planned for local treatment * Cohort 2: Re-irradiation * Previous radiation in the current area of disease requiring radiation * Life expectancy of \>3 months as defined by agreement of both the Chow et al.15 and TEACHH16 models Exclusion Criteria: * SBRT target size \>6 cm in maximum diameter (or \>100 cc in volume) * Hematologic malignancies (including lymphoma, multiple myeloma) * Prior RT of greater dose intensity than 100 Gy2 based on a biological effective dose (BED) calculation \[BED (Gy2) = nd x (1+d/α/ß; where n=number of fractions, d=dose per fraction, α/ß=2)\] * Epidural tumor \<2 mm from spinal cord * Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent hormonal therapies are allowed) * Inability to lie flat and still for treatment delivery despite anti-anxiety and/or pain medications * Non-English speakers are excluded from this study due to use of questionnaires which have not been validated in other languages. * Patients lacking the capacity to describe their symptoms are excluded as that precludes them (or anyone on their behalf) from filling out the validated questionnaires about symptoms/toxicity. * Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. * Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated within the past 2 years for cervical cancer in situ or basal cell or squamous cell carcinoma of the skin.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.