Trial · NCT04220229
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Secondary | Rate of Treatment Discontinuation Prior to Neoadjuvant Radiation Therapy | Up to 1 year | Evaluated utilizing the Exact Clopper-Pearson method. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04220229/registered