NCT03158610

Brief Summary

Based upon biological behavior, those mCRC patients who respond well (SD, PR or CR according to RECIST Criteria) after 16-18 weeks of standard doublet chemotherapy as induction may enrolled into this study, randomly divided into capecitabine metronomic group or standard dosage group. The duration of disease control after randomization(PFS2) and progression free survival from enrollment (PFS1) are primary endpoints. Meanwhile, the overall survival, safety and quality of life are secondary endpoints. Exploratory markers involving angiogenesis (serum VEGF, PDGF, Tie-1 and Tie2, etc) and immune function (CD clusters, serum tumor mutation burden(TMB), etc), are conducted via liquid biopsy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
terminated

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 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

3.2 years

First QC Date

May 15, 2017

Last Update Submit

April 28, 2021

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression Free Survival 1 (PFS1)

    from enrollment to progression

    10 months

  • Progression Free Survival 2 (PFS2)

    from randomization to progression

    4 months

Secondary Outcomes (3)

  • Overall Survival (OS)

    20 months

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

    20 months

  • Number of participants with quality of life (QoL) as assessed by CTCAE v4.0

    20 months

Study Arms (2)

Capecitabine metronomic chemotherapy

EXPERIMENTAL

Capecitabine 500mg/m2 bid po qd

Drug: Capecitabine

Capecitabine standard dosage chemotherapy

ACTIVE COMPARATOR

Capecitabine 1000mg/m2 bid po d1-d14,q3w

Drug: Capecitabine

Interventions

CapecitabineDRUG

Oral fluorouracil

Also known as: Xeloda
Capecitabine metronomic chemotherapyCapecitabine standard dosage chemotherapy

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 which are unresectable (patients with only local recurrence are not eligible);
  • 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;

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
  • At randomisation:
  • WHO performance status 0-1 (Karnofsky PS \> 70%);
  • Disease evaluation with proven SD, PR or CR according to RECIST after first-line induction treatment;
  • Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow function (Hb \> 6.0 mmol/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, \> 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases);
  • Life expectancy \> 12 weeks;
  • Age: 18-75 years;
  • Negative pregnancy test in women with childbearing potential;
  • Expected adequacy of follow-up;
  • Institutional Review Board approval;
  • Chronic active infection;
  • Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Ruijin Hospital

Shanghai, 200025, China

Location

Related Publications (5)

  • Kareva I, Waxman DJ, Lakka Klement G. Metronomic chemotherapy: an attractive alternative to maximum tolerated dose therapy that can activate anti-tumor immunity and minimize therapeutic resistance. Cancer Lett. 2015 Mar 28;358(2):100-106. doi: 10.1016/j.canlet.2014.12.039. Epub 2014 Dec 23.

    PMID: 25541061BACKGROUND

  • Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.

    PMID: 16421419BACKGROUND

  • Andre T, Tournigand C, Mineur L, Fellague-Chebra R, Flesch M, Mabro M, Hebbar M, Postel Vinay S, Bidard FC, Louvet C, de Gramont A. Phase II study of an optimized 5-fluorouracil-oxaliplatin strategy (OPTIMOX2) with celecoxib in metastatic colorectal cancer: a GERCOR study. Ann Oncol. 2007 Jan;18(1):77-81. doi: 10.1093/annonc/mdl336. Epub 2006 Oct 9.

    PMID: 17030548BACKGROUND

  • 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

  • Shi M, Ma T, Xi W, Jiang J, Wu J, Zhou C, Yang C, Zhu Z, Zhang J. A study of capecitabine metronomic chemotherapy is non-inferior to conventional chemotherapy as maintenance strategy in responders after induction therapy in metastatic colorectal cancer. Trials. 2020 Mar 6;21(1):249. doi: 10.1186/s13063-020-4194-6.

    PMID: 32143730DERIVED

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

  • Jun Zhang, MD & Ph. D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

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
Deputy-chief of Department of Oncology

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 18, 2017

Study Start

January 29, 2018

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

CN(1)