Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

NCT02043821 | Unknown DMC

• 1 other identifier: 20140116
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• DDC:Duration of Disease Control

  progression-free survival of first-line chemotherapy with second-line chemotherapy

  2 years

Secondary Outcomes (2)

• OS:Overall Survival

  2 years

• DCR:Disease Control Rate

  2 years

Other Outcomes (1)

• Safety

  2 years

Study Arms (2)

Placebo

OTHER

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

Other: placebo

Capecitabine

EXPERIMENTAL

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

Drug: Capecitabine

Interventions

Capecitabine DRUG

14days

Capecitabine

placebo OTHER

14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Guangyu An, PhD

  Beijing Chao Yang Hospital

  STUDY DIRECTOR

Central Study Contacts

Dong Yan, PhD

CONTACT

13621308215; yd15yt88@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Chao Yang Hospital

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Primary Completion: January 1, 2016
• Last Updated: January 24, 2014

Record last verified: 2014-01