A 6 microRNA Tool for Stratifying Stage II Colon Cancer of Receiving Adjuvant Chemotherapy

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Colonic Neoplasms; Effects of Chemotherapy

Treatments: Other: A classic stratified tool; Other: A 6 microRNA stratified tool

Study type: Interventional

Funder types: Other

Identifiers

NCT02466113

2015[28]

Details and patient eligibility

About

Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is still on debate.MicroRNA(miRNA) is a promising tool. Investigators invented a tool consisting of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that was effective to identify one should accept adjuvant chemotherapy or not. Here investigators randomly assign patients to be assessed by classical pathological features or the miRNA tool of determining who should accept chemotherapy. Disease free survival and overall survival are the end points of observation.

Full description

Investigators randomly assign patients to be assessed by classical pathological features(control group) or the miRNA tool(experimental group). Pathological features include poorly differentiated histology(exclusive of those cancers that are MSI-H),lymphatic/vascular invasion,bowel obstruction and <12 lymph nodes examined.MicroRNA tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215. Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miR-21-5p)+(0.086×status of miR-20a-5p)+(0.240×status of miR-103a-3p)+(0.095×status of miR-106b-5p)-(0.238×status of miR-143-5p)-(0.237×status of miR-215),low expression status equals 0 and high expression status equals 1). Investigators defined high risk patient if had any pathological features in control group or the score larger than 1 in the experimental group ,the others as low risk patient.The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation. Primary endpoint is the disease free survival and overall survival.

Enrollment: 430 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The informed consent has been obtained from the patient.
• With confirmed diagnosis of stage II colon cancer.
• With moderate/good ECOG health rating (PS): 0-1 score.
• The patient receive no anti-cancer treatment before primary surgery.
• The patient receive radical operation for colon cancer with negative margin.

Exclusion criteria

• With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
• With bad compliance or contraindication to enrollment.
• Pregnant woman or lactating woman.
• With contraindication to receive adjuvant chemotherapy.

Trial design

430 participants in 2 patient groups

An experimental group

Experimental group

Description:

A 6 microRNA stratified tool is applied in this group.Investigators defined high risk patient and low risk patient according to the microRNA stratified tool.The high risk group should receive adjuvant chemotherapy while the low risk group observation.

Treatment:

Other: A 6 microRNA stratified tool

A control group

Other group

Description:

A classic stratified tool is applied in this group. Investigators defined high risk and low risk patient according to classical pathological features.The high risk group should receive adjuvant chemotherapy while the low risk group observation.

Treatment:

Other: A classic stratified tool