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CompletedNCT03564912Updated Aug 25, 2021

Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in CRC

A Phase 1/2 interventional study of Capecitabine Oral Tablet [Xeloda] in Colorectal Cancer, sponsored by Zhejiang University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Zhejiang University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2021, 5 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1/2
Study type
Interventional
Enrollment
160
Allocation
Non-randomized
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 160 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    2 week group

    Drug: Capecitabine Oral Tablet [Xeloda]

  • Active comparator
    3 week group

    Drug: Capecitabine Oral Tablet [Xeloda]

Interventions

  • DrugCapecitabine Oral Tablet [Xeloda]

    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

06

What researchers measure

Primary outcomes

  1. DFS

    disease free survival

    Time frame: 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

    toxicity difference of two groups

    Time frame: 2 weeks

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Study locations

1 site
  • First afflicated hospital of zhejiang university
    Hangzhou, Zhejiang 310000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03564912
Lead sponsor
Zhejiang University
Responsible party
Weijia Fang, MD (director, Zhejiang University) — Principal investigator
First posted
Jun 21, 2018
Start date
Aug 12, 2018
Primary completion
Aug 24, 2021
Completion
Aug 24, 2021
Last update
Aug 25, 2021

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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