Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: Capecitabine

• Registration Number: NCT02893540
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-03
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16
• Primary Completion: 2018-12
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Capecitabine	accept capecitabine conventional chemotherapy (1000mg/m2, twice per day for 14 days, every 21 days)
Metronomic	Capecitabine	accept capecitabine metronomic chemotherapy (500mg, twice per day, everyday)

Primary Outcome Measures

Name	Time	Method
PFS1	4 months	from randomizing to progression

Secondary Outcome Measures

Name	Time	Method
QOL	20 months	QLQ-C30
OS	20 months	from signing informed consent form to death

Trial Locations

Locations (1)

Shanghai Rui Jin Hospital; 🇨🇳 Shanghai, Shanghai, China