Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metronomic

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

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

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

Conventional

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

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

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

Interventions

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Capecitabine

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

Intervention Type DRUG

Other Intervention Names

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Xeloda

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No