Trial · NCT04163952
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Up to 30 days | Number of participants who experience adverse effects greater than or equal to a grade three as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Grade 1-4, with 4 being the most severe. |
| Primary | Response Rate to Panitumumab as Measured by Evaluation of the Criteria in Solid Tumors (RECIST) 1.1. | Up to two years | Response will be evaluated by using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Changes in the largest diameter (unidimensional measurement)of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements. |
| Secondary | Best Overall Response Rate (ORR) of Participants From Start to Progression of Disease | Up to two years | Best response on treatment was based on RECIST 1.1 criteria. Complete response (CR) is complete disappearance of all targeted lesions. Partial response (PR) is at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference baseline sum. LD Progressive disease (PD) is at least 20% increase in the sum of the longest diameter of the targeted lesions, taking as reference the smallest sum recorded in treatment PD for the evaluation of non-targeted lesions is the appearance of one or more new lesions and or progression of non-targeted lesions. Stable disease is defined as any condition not meet above criteria. The response rate of the drug will be assessed according to the decision rule based on Simons two-stage design. |
| Secondary | Durable Response Rate Based on Simons Two-stage Design | Up to two years | Will be defined as the percent of participants with complete response or partial response maintained continuously for a minimum of six months. The response rate of the drug will be assessed according to the decision rule based on Simons two-stage design. |
| Secondary | Duration of Response Based on Simons Two-stage Design | Time from initial response until document progression up to two years | The response rate of the drug will be assessed according to the decision rule based on Simon?s two-stage design. |
| Secondary | Progression-free Survival (PFS) to Assess Participants Progressive Free-survival | From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to 2 years | The estimate of PFS will be performed by the Kaplan-Meier product limit model.\>valuated by RECIST 1.1. |
| Secondary | Change in Overall Survival (OS) Measured by the Kaplan-Meier | From date of enrollment to the date of death or date last known alive, whichever comes first, assessed up to assessed up to two years | The estimate of OS will be performed by the Kaplan-Meier product limit model. |
| Secondary | Mutation Load in Tumor Tissue Measured by Next Generation Sequencing | Up to two years | Next generation sequencing (NGS) is a massively parallel sequencing technology that offers ultra-high throughput, scalability, and speed. The technology is used to determine the order of nucleotides in entire genomes or targeted regions of DNA or RNA, and has the ability to detect variants at lower allele frequencies. With response to therapy and but the actual knowledge of the genetic basis of participants disease. |
| Secondary | Deoxyribonucleic Acid Mutation Signature in Tumor Tissue | Up to two years | Will be analyzed by next generation sequencing with response to therapy. |
| Secondary | Messenger Ribonucleic Acid Signature in Tumor Tissue Measured by Nanostring Technology | Up to two years | Nanostring is an amplification-free technology that measures nucleic acid content by counting molecules directly. NanoString provides several pre-made gene expression panels that examine up to 770 genes at once and custom CodeSets for up to 800 targets. With response to therapy and descriptive statistics applied. |
| Secondary | Immune Cell Populations in Tumor Tissue | Up to two years | Will be analyzed by flow cytometry with response to therapy. |
| Secondary | Immune Cell Populations Peripheral Blood as Measured by Flow Cytometry | Up to two years | Cytometry, in its purest form, is the measurement of cell characteristics. Flow cytometry can identify the type of cells in a blood or bone marrow sample, including the types of cancer cells. It detects types of cancer cells based on either the presence or the absence of certain protein markers (antigens) on a cell's surface. This technique allows researchers to get highly specific information about individual cells. Flow cytometry will be used, with response to therapy and descriptive statistics applied. |
| Secondary | Expression of Cytokines in Tumor Tissue | Up to two years | Will be analyzed by flow cytometry, any suspended particle or cell from 0.2-150 micrometers in size, is suitable for analysis. |
| Secondary | Expression of Cytokines in Peripheral Blood | Up to two years | Will be analyzed by flow cytometry, any suspended particle or cell from 0.2-150 micrometers in size is suitable for analysis, with response to therapy. |
| Secondary | Pathologic Complete Response Rate | Up to two years | Pathologic complete response (pCR) was defined as percent necrosis of the surgical specimen greater than or equal to 90% .Pathologic complete response (pCR) is a surrogate endpoint to demonstrate the study drug's efficacy. |
| Secondary | Time to Resectability | Up to two years | A resectable tumor is one in which there is no technical barrier to surgical excision. Able to be removed by surgery. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04163952/registered