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Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Capecitabine

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Rui Jin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Metronomic

Conventional

Arm Description

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

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

Outcomes

Primary Outcome Measures

PFS1

from randomizing to progression

Secondary Outcome Measures

from signing informed consent form to death

QOL

QLQ-C30

Full Information

NCT ID

NCT02893540

First Posted

September 3, 2016

Last Updated

September 15, 2016

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02893540

Brief Title

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

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metronomic

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Primary Outcome Measure Information:

Title

PFS1

Description

from randomizing to progression

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Description

from signing informed consent form to death

Time Frame

20 months

Title

QOL

Description

QLQ-C30

Time Frame

20 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

HAO LI, MD，Ph.D

Phone

86-15000929050

drlihao@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

JUN ZHANG, MD，Ph.D

Phone

86-18917762326

junzhang@188.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yifeng Wang, MD

Organizational Affiliation

Shanghai Rui Jin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Rui Jin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yifeng Wang

Phone

8621-64370045

Ext

665879

wyfkjc@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25862517

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.

Results Reference

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PubMed Identifier

26940686

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.

Results Reference

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Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC

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