NCT03564912

Brief Summary

This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1 colorectal-cancer

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 12, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

May 27, 2018

Last Update Submit

August 24, 2021

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • DFS

    disease free survival

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    2 weeks

Study Arms (2)

2 week group

EXPERIMENTAL
Drug: Capecitabine Oral Tablet [Xeloda]

3 week group

ACTIVE COMPARATOR
Drug: Capecitabine Oral Tablet [Xeloda]

Interventions

Capecitabine Oral Tablet [Xeloda]DRUG

2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w

Also known as: oxaliplatin
2 week group3 week group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Carcinoma of the intestine confirmed histologically or cytologically
  • Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients
  • The ECOG PS score less than or equal to 2 points
  • No chemotherapy of any kind has been performed in the past
  • Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL
  • liver function transaminase is less than or equal to 2.5 ULN, alkaline phosphatase is less than 2.5 ULN, and total bilirubin is less than 1.5 ULN

You may not qualify if:

  • Patients with unresectable CRC
  • Patients who have any form of chemotherapy before
  • Participating in or having participated in clinical studies of other drug
  • Patients have second primary malignant tumors of have other malignant tumors in the past five years
  • There is evidence of allergic reaction to drugs in this study
  • A history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias
  • Severe active inflammation, including tuberculosis and HIV
  • Long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose
  • Drug or alcohol addiction
  • Get pregnant or breastfeed
  • The investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First afflicated hospital of zhejiang university

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

  • Zhang H, Wang D, Tong Z, Xiang T, Zhu X, Liu L, Zheng Y, Zhao P, Fang W, Chen W. Biweekly CAPOX versus triweekly CAPOX in the adjuvant therapy of post-surgery CRC: A randomized controlled trial. PLoS One. 2025 Jul 11;20(7):e0313472. doi: 10.1371/journal.pone.0313472. eCollection 2025.

    PMID: 40644418DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

May 27, 2018

First Posted

June 21, 2018

Study Start

August 12, 2018

Primary Completion

August 24, 2021

Study Completion

August 24, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

CN(1)