A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.

NCT02135887 | Unknown DMC

• 1 other identifier: MB104CLCT02
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.

Conditions

Stage III Colorectal Cancer; Neutropenia

Keywords

Stage III Colorectal Cancer; Grade 4 Neutropenia; MB-6

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.

  The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)\<500/mm3

  18 weeks

Secondary Outcomes (8)

• Time to first Grade 4 Neutropenia

  18 weeks

• Incidence of Febrile Neutropenia

  18 weeks

• Incidence of Grade 3 or 4 Neutropenia

  18 weeks

• Change in Serum Creatinine level

  18 weeks

• Health-Related Quality of Life (HRQoL) - QLQ-C30

  18 weeks

Study Arms (2)

MB-6+FOLFOX chemotherapy

MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks

Drug: MB-6

Placebo+FOLFOX chemotherapy

Placebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks

Drug: Placebo

Interventions

MB-6 DRUG

6# TID with meal

Also known as: Folinic acid; Fluorouracil ; Oxaliplatin

MB-6+FOLFOX chemotherapy

Placebo DRUG

6# TID with meal

Also known as: Folinic acid; Fluorouracil ; Oxaliplatin

Placebo+FOLFOX chemotherapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 184 patients with stage III colorectal cancer underwent surgery will be recruited into the study for receiving adjuvant therapy over 18 weeks.

You may qualify if:

• Men or women 20 years of age or older.
• Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.
• Complete resection of the primary tumor without gross or microscopic evidence of residual disease.
• No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) \< 2 at the time of screening.
• Hematological function: ANC≥1500/mm3, Hemoglobin ≥9.0 g/dL, Platelet count ≥100000/mm3.
• Kidney function:Serum creatinine \<2 mg/dL.
• Liver function: AST ≤3 times ULN, ALT ≤3 times ULN, Total Bilirubin ≤2 times ULN.
• Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
• Men and women of childbearing potential must agree to employ adequate contraception during the study period.

You may not qualify if:

• History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
• Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization.
• Concurrent treatment with any other anticancer therapy.
• Radiotherapy ≤14 days prior to randomization.
• Any unresolved toxicity \> CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia.
• Patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator.
• Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC \>1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization.
• Patient of child-bearing potential is evidently pregnant or is breast feeding.

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Sites (1)

Microbio Co., Ltd.

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neutropenia

Interventions

Leucovorin; Fluorouracil; Oxaliplatin

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; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• William Chen, M.D.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Chen, M.D.

CONTACT

886-4-22052121; wtchen@mail.cmuh.org.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 12, 2014
• Study Start: November 4, 2013
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

TW (1)