CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 100 target
Drug / intervention
Capecitabinedrug
Likely dose
Capecitabine 1000mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01880658
NCT01880658Phase 2Unknown
CompareCT.gov

Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV

Sun Yat-sen University·interventional·Posted Jun 19, 2013·Updated Feb 11, 2014

In Brief

A Phase 2 clinical trial evaluating Capecitabine for Colorectal Neoplasms. Targeting 100 participants across 1 site.

Detailed Summary

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy with capecitabine is still unknown. PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy followed by maintenance therapy with capecitabine to see the efficacy and safety, then to investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
2014201520162017201820192020202120222023202420252026
First PostedJun 19, 2013
Enrollment StartJun 1, 2013
Primary CompletionMay 1, 2016
Study CompletionMay 1, 2019
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 13.0 years ago

Interventions

Capecitabinedrug

Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)