Trial · NCT03297710
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) | Up to 28 days | Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients. |
| Other | Best response as evaluated by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria | Best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started), assessed up to 6 months | Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. |
| Other | Incidence and severity of adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Up to 6 months | Will be tabulated and summarized. |
| Other | Incidence of toxicities graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Up to 6 months | Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. |
| Other | Median progression free survival | Up to 6 months | Kaplan Meier curves will be utilized to estimate the median progression free survival in the expansion cohort. |
| Other | Number of patients that make it to surgery | Up to 6 months | Will assess rates of pathologic complete response (pCR), tumor regression grade (TRG), and rates of R0 resection. |
| Other | Overall survival | Up to 6 months | Kaplan Meier curves will be utilized to estimate the overall survival in the expansion cohort. |
| Other | Quality of life (QoL) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Up to 6 months | Descriptive statistics of testing measures, including patients' pain and quality of life scores, will be calculated and correlated to treatment dose and response. |
| Other | Time to progression | Up to 6 months | Will be summarized descriptively. |
| Other | Time to treatment failure | From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 6 months | Will be summarized descriptively. |
| Other | Time until any treatment related toxicity | Up to 6 months | Will be summarized descriptively. |
| Other | Time until hematologic nadirs (absolute neutrophil count [ANC], platelets, hemoglobin) | Up to 6 months | Will be summarized descriptively. |
| Other | Time until treatment related grade 3+ toxicity | Up to 6 months | Will be summarized descriptively. |
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/NCT03297710/registered