Trial · NCT02280070
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-years Disease Free Survival rate | 3 years from the enrollment | The last analysis after the follow-up period is conducted. The disease-free survival ratio that assumed full analysis set (FAS) as a denominator is estimating by Kaplan-Meier method at 3 year, up to 5 years after the last subject enrollment. |
| Secondary | Pathological Effect | After operation, up to 5 years after the last subject enrollment. | The pathological effect of protocol treatment as FAS a denominator is evaluated according to the criteria of Japanese Classification of Colorectal Carcinoma 7th revision |
| Secondary | R0 resection rate | At operation, up to 5 years after the last subject enrollment. | The R0 resection rate is defined as a ratio of case that conducted R0 resection in FAS. |
| Secondary | Completion rate of each modality (neoadjuvant chemotherapy, operation and adjuvant chemotherapy) | After completion of protocol treatment, up to 5 years after the last subject enrollment. | The rate completed 4 courses of neo-adjuvant chemotherapy within protocol treatment is defined as the completion rate of neo-adjuvant therapy in FAS. Among the cases that an resection operation are enforced and that adjuvant chemotherapy is planned after the operation, the rate completed 4 courses of adjuvant chemotherapy within protocol treatment is defined as the completion rate of adjuvant therapy |
| Secondary | Overall survival (OS) | Up to 5 years after the last subject enrollment. | Overall survival is defined as a period from an enrollment date to a death from every cause in FAS. |
| Secondary | Disease Free survival (DFS) | The date of recurrence, occurrence of secondary cancer and death, up to 5 years after the last subject enrollment. | DFS is defined as the period from a registration day to the day of recurrence, the day of diagnosis of secondary cancer and the day of the death of every cause in FAS. |
| Secondary | OS in patients with R0 resection | At the date of death, up to 5 years after the last subject enrollment. | OS in patients with R0 resection is defined as a period from a enrollment day to the date of death from every cause in patients with R0 resection in FAS. |
| Secondary | DFS in patients with R0 resection | The date of recurrence, occurrence of secondary cancer and death, up to 5 years after the last subject enrollment. | DFS in patients with R0 resection is defined as the period from a enrollment day to the day of recurrence, the day of diagnosis of secondary cancer and the day of the death of every cause in patients with R0 resection in FAS. |
| Secondary | Transition rate to Operation | At the operation, up to 5 years after the last subject enrollment. | The transition rate to operation is defined as the rate of case transited to the resection operation in FAS. |
| Secondary | local recurrence rate (per operated population) | After the operation, up to 5 years after the last subject enrollment. | The local recurrence rate is defined as the recurrence rate of operated population. |
| Secondary | Safety | Within protocol treatment, up to 5 years after the last subject enrollment. | The frequency of worst Grade of the adverse event (toxicity) in all courses with the CTCAE v4.0 Japanese translated JCOG version is calculated in each group about the cases for the safety analysis a denominator |
| Secondary | Pattern of first recurrence | At the study completion, up to 5 years after the last subject enrollment. | Pattern of first recurrence is investigated in FAS. |
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/NCT02280070/registered