Clinical trial NCT02893540: Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC
Official title: Capecitabine Metronomic Chemotherapy Versus Conventional Chemotherapy as Maintenance Treatment in Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In this Prospective, open-label, randomised controlled trial, the investigators will recruit 250 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. Then, the patients will be randomised into two group. The experimental group, capecitabine metronomic chemotherapy versus capecitabine conventional chemotherapy as control group. These treatment regimens will be continued until progression, death, or an unacceptable adverse event.

The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PFS1
timeFrame: 4 months
Secondary outcomes:
measure: OS
timeFrame: 20 months
measure: QOL
timeFrame: 20 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Rui Jin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Rui Jin Hospital
name: Yifeng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.