Trial · NCT04220229
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities
NCT04220229, Phase 1, Phase 2, Terminated, University of Washington; results first posted 2025-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities. Trials, record NCT04220229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04220229
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities
- NCT number
- NCT04220229
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Sarcoma of the Extremity, Stage I Soft Tissue Sarcoma of the Trunk and Extremities, Stage IA Soft Tissue Sarcoma of the Trunk and Extremities, Stage IB Soft Tissue Sarcoma of the Trunk and Extremities, Stage II Soft Tissue Sarcoma of the Trunk and Extremities
- Interventions
- Cabozantinib S-malate, Radiation Therapy
- First posted
- 2020-01-07
- Last updated
- 2025-07-17
- Results first posted
- 2025-07-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I) | Up to 21 days | Cabozantinib treatment begins 8 days prior to initiation of radiation therapy and continues through completion of radiation therapy. |
| Primary | Rate of Relapse (Phase II) | At 12 months after treatment initiation | No patients were enrolled in Phase II portion of study - outcome measure based on Phase I patients. |
| Secondary | Rate of Pathologic Response(>90%) | Up to 1 year | Evaluated utilizing the Exact Clopper-Pearson method. |
| Secondary | Rate of Surgical Excision With Negative Margins | Up to 1 year | Evaluated utilizing the Exact Clopper-Pearson method. |
| Secondary | Objective Response Rate | Up to 1 year | Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Includes those who had complete response and partial response. |
| Secondary | Rate of Local Relapse | Up to 3 years | Evaluated utilizing the Exact Clopper-Pearson method. |
| Secondary | Rate of Distant Relapse | Up to 3 years | Evaluated utilizing the Exact Clopper-Pearson method. |
| Secondary | Relapse-free Survival | Up to 1 year | Evaluated utilizing the Exact Clopper-Pearson method. |
| Secondary | Overall Survival | Up to 1 year | Evaluated utilizing the Exact Clopper-Pearson method. |
| Secondary | Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib. | Up to 30 days after last dose of investigational product (an average of up to 12 weeks) | Adverse events will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I) | Up to 21 days | mg | NUMBER | |
| PRIMARY | Rate of Relapse (Phase II) | At 12 months after treatment initiation | percentage of participants | NUMBER | |
| SECONDARY | Rate of Pathologic Response(>90%) | Up to 1 year | percentage of participants | NUMBER | |
| SECONDARY | Rate of Surgical Excision With Negative Margins | Up to 1 year | percentage of participants | NUMBER | |
| SECONDARY | Objective Response Rate | Up to 1 year | percentage of participants | NUMBER | |
| SECONDARY | Rate of Local Relapse | Up to 3 years | precentage of participants | NUMBER | |
| SECONDARY | Rate of Distant Relapse | Up to 3 years | percentage of participants | NUMBER | |
| SECONDARY | Relapse-free Survival | Up to 1 year | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | Up to 1 year | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib. | Up to 30 days after last dose of investigational product (an average of up to 12 weeks) | adverse events experienced | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I) | Treatment (Cabozantinib S-malate, Radiation Therapy) | 60 | mg | ||
| Rate of Relapse (Phase II) | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 0 | 95% Confidence Interval 0 to 71 | percentage of participants | |
| Rate of Relapse (Phase II) | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 33 | 95% Confidence Interval 0 to 91 | percentage of participants | |
| Rate of Pathologic Response(>90%) | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 0 | 95% Confidence Interval 0 to 71 | percentage of participants | |
| Rate of Pathologic Response(>90%) | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 33 | 95% Confidence Interval 0 to 91 | percentage of participants | |
| Rate of Surgical Excision With Negative Margins | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 100 | 95% Confidence Interval 29 to 100 | percentage of participants | |
| Rate of Surgical Excision With Negative Margins | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 100 | 95% Confidence Interval 29 to 100 | percentage of participants | |
| Objective Response Rate | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 0 | 95% Confidence Interval 0 to 71 | percentage of participants | |
| Objective Response Rate | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 0 | 95% Confidence Interval 0 to 71 | percentage of participants | |
| Rate of Local Relapse | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 0 | 95% Confidence Interval 0 to 71 | precentage of participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (40 mg Cabozantinib S-malate, Radiation Therapy) | 3 | |
| Overall Study | STARTED | Treatment (60 mg Cabozantinib S-malate, Radiation Therapy) | 3 | |
| Overall Study | COMPLETED | Treatment (40 mg Cabozantinib S-malate, Radiation Therapy) | 3 | |
| Overall Study | COMPLETED | Treatment (60 mg Cabozantinib S-malate, Radiation Therapy) | 3 | |
| Overall Study | NOT COMPLETED | Treatment (40 mg Cabozantinib S-malate, Radiation Therapy) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (60 mg Cabozantinib S-malate, Radiation Therapy) | 0 |
Source ClinicalTrials.gov
Adverse events122
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mucositis oral | Gastrointestinal disorders | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 3 | 3 | 3 |
| other | Mucositis oral | Gastrointestinal disorders | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 3 | 3 | 3 |
| other | Tumor Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 3 | 3 | 4 |
| other | Tumor Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 1 | 3 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 1 | 3 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 2 | 3 | 2 |
| other | Alanine aminotransferase increased | Investigations | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 1 | 3 | 1 |
| other | Alanine aminotransferase increased | Investigations | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 0 | 3 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 1 | 3 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 0 | 3 | 0 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 1 | 3 |
| Total, all-cause mortality | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 0 | 3 |
| Total, other adverse events | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 3 | 3 |
| Total, other adverse events | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 3 | 3 |
| Total, serious adverse events | Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy | 0 | 3 |
| Total, serious adverse events | Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy | 0 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32827353 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy vs Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy: deaths from any cause | Trial comparisons |
| Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy vs Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04220229
GET https://conductscience.org/api/trials/v1/NCT04220229/results?page=2