Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC

Colorectal Cancer Clinical Trial

Official title:

Capecitabine Metronomic Chemotherapy Versus Conventional Chemotherapy as Maintenance Treatment in Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02893540
• Other study ID #: RJH-Oncol-Metronomic
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 3, 2016
• Last updated: September 15, 2016
• Start date: September 2016
• Est. completion date: August 2019

Study information

• Verified date: September 2016
• Source: Ruijin Hospital
• Contact: HAO LI, MD,Ph.D
• Phone: 86-15000929050
• Email: drlihao[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine
we are going to compare two maintenance treatment models with capecitabine in this study

Locations

Country	Name	City	State
China	Shanghai Rui Jin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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):1074-81. doi: 10.1093/annonc/mdw101. Epub 2016 Mar 2. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS1	from randomizing to progression	4 months	No
Secondary	OS	from signing informed consent form to death	20 months	No
Secondary	QOL	QLQ-C30	20 months	Yes