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Colorectal CancerPhase 2/3NCT03158610

Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Metastatic Colorectal Cancer

A Phase 2/3 study testing Capecitabine in people with Colorectal Cancer, run by Ruijin Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
29 Jan 2018to 28 Apr 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • 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);
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  • 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;
  • Written informed consent Exclusion criteria
  • Chronic active infection;
  • Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs;

Who cannot join

  • 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:

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Oncology, Ruijin Hospital

    Shanghai, 200025

Other trials in China

About this study

Official title: Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Responders After Induction Therapy in Metastatic Colorectal Cancer

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.

Read the detailed description

This study is try to evaluate the effect of capecitabine metronomic chemotherapy as maintenance treatment, which compare to capecitabine conventional chemotherapy, who have responded to 16-18 months first-line chemotherapy in metastatic colorectal cancer (mCRC). The maintenance treatments are continued until disease progression or severe toxicity. The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy. Furthermore, 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.

Being tested
Capecitabine
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03158610
Study groupRoleWhat they receive
Capecitabine metronomic chemotherapyExperimentalCapecitabine 500mg/m2 bid po qd
Receives: Drug: Capecitabine
Capecitabine standard dosage chemotherapyActive comparatorCapecitabine 1000mg/m2 bid po d1-d14,q3w
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival 1 (PFS1)

    from enrollment to progression

    Measured: 10 months

  2. Progression Free Survival 2 (PFS2)

    from randomization to progression

    Measured: 4 months

Secondary outcomes (3)

  1. Overall Survival (OS)

    from signing informed consent to death

    Measured: 20 months

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

    drug related toxicity from signing informed consent to death

    Measured: 20 months

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

    QoL from signing informed consent to death

    Measured: 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2017
  2. Study start29 Jan 2018
  3. Primary completion28 Apr 2021
  4. Study completion28 Apr 2021

Why it stopped: Difficult to enrollment patient

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03158610
Sponsor's protocol ID
BIG-MOON
Status last verified
Apr 2021
First submitted
15 May 2017
Last updated
3 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25541061

  • 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.

    PubMed 16421419

  • 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.

    PubMed 17030548

  • 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.

    PubMed 25862517

  • 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.

    PubMed 32143730

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Capecitabine in people with Colorectal Cancer, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficult to enrollment patient). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival 1 (PFS1) (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03158610, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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