Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

NCT ID: NCT02043821

Last Updated: 2014-01-24

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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Detailed Description

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Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days

Group Type OTHER

placebo

Intervention Type OTHER

14 days

Capecitabine

Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

14days

Interventions

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Capecitabine

14days

Intervention Type DRUG

placebo

14 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions \< 1.5 upper normal limit (UNL).

Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent

Exclusion Criteria

\- Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Yan

Beijing Chao Yang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guangyu An, PhD

Role: STUDY_DIRECTOR

Beijing Chao Yang Hospital

Central Contacts

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Dong Yan, PhD

Role: CONTACT

13621308215

Other Identifiers

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20140116

Identifier Type: -

Identifier Source: org_study_id

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