NCT02893540

Brief Summary

The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy versus conventional chemotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

September 3, 2016

Last Update Submit

September 15, 2016

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS1

    from randomizing to progression

    4 months

Secondary Outcomes (2)

  • OS

    20 months

  • QOL

    20 months

Study Arms (2)

Metronomic

EXPERIMENTAL

accept capecitabine metronomic chemotherapy (500mg, twice per day, everyday)

Drug: Capecitabine

Conventional

ACTIVE COMPARATOR

accept capecitabine conventional chemotherapy (1000mg/m2, twice per day for 14 days, every 21 days)

Drug: Capecitabine

Interventions

CapecitabineDRUG

we are going to compare two maintenance treatment models with capecitabine in this study

Also known as: Xeloda
ConventionalMetronomic

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
  • Distant metastases (patients with only local recurrence are not eligible);
  • Unidimensionally measurable disease (\> 1 cm on spiral CT scan or \> 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
  • In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.

You may not qualify if:

  • Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment;
  • Any prior adjuvant treatment after resection of distant metastases;
  • Previous systemic treatment for advanced disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Rui Jin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (2)

  • Simkens LH, van Tinteren H, May A, ten Tije AJ, Creemers GJ, Loosveld OJ, de Jongh FE, Erdkamp FL, Erjavec Z, van der Torren AM, Tol J, Braun HJ, Nieboer P, van der Hoeven JJ, Haasjes JG, Jansen RL, Wals J, Cats A, Derleyn VA, Honkoop AH, Mol L, Punt CJ, Koopman M. Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group. Lancet. 2015 May 9;385(9980):1843-52. doi: 10.1016/S0140-6736(14)62004-3. Epub 2015 Apr 7.

    PMID: 25862517BACKGROUND

  • Luo HY, Li YH, Wang W, Wang ZQ, Yuan X, Ma D, Wang FH, Zhang DS, Lin DR, Lin YC, Jia J, Hu XH, Peng JW, Xu RH. Single-agent capecitabine as maintenance therapy after induction of XELOX (or FOLFOX) in first-line treatment of metastatic colorectal cancer: randomized clinical trial of efficacy and safety. Ann Oncol. 2016 Jun;27(6):1074-1081. doi: 10.1093/annonc/mdw101. Epub 2016 Mar 2.

    PMID: 26940686BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

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 Nucleosides

Study Officials

  • Yifeng Wang, MD

    Shanghai Rui Jin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HAO LI, MD，Ph.D

CONTACT

86-15000929050drlihao@163.com

JUN ZHANG, MD，Ph.D

CONTACT

86-18917762326junzhang@188.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

September 3, 2016

First Posted

September 8, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

August 1, 2019

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

CN(1)