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Early trial combines two chemo drugs with radiation for aggressive sarcomas

NCT ID NCT04037527

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This Phase 1 trial tested a combination of two chemotherapy drugs (gemcitabine and docetaxel) given alongside radiation therapy for adults with large (over 5 cm), high-grade soft tissue sarcoma of the arms or legs. The goal was to find the safest dose and see how well the body tolerates the treatment. Only 9 people took part before the study was stopped early.

What this could mean

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

Active substance
gemcitabine and docetaxel (chemotherapy drugs) plus radiation therapy
What this could lead to
If it works, this could point toward a way to shrink large, high-grade sarcomas before surgery using a combination of chemo and radiation.
What could go wrong
This was a very early Phase 1 safety study with only 9 participants and was terminated early. The combination may cause significant side effects, and it is unknown if it will improve outcomes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Aug 2020

Finished

Jun 2024

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: * Patients must have a histologically or cytologically confirmed Grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation. * Age greater than or equal to 18 years. No children will be enrolled on this protocol. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives. * Patients taking an investigational agent are excluded. * Pregnant and nursing women are excluded. * Patients who require amputation for local control. * Patients who underwent unplanned excision or other previous surgery involving the affected extremity. * Patients with sarcoma subtypes for which established chemotherapeutic regimens exist. * History of radiation to the limb.

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Conditions

The condition(s) this trial relates to.

sarcoma soft tissue sarcoma

As listed by the trial registrant

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

Soft tissue sarcoma

Contacts and locations

Locations

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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