IL-6/STAT3 for prediction of response after neoadjuvant chemoradiation therapy for stages II-III rectal cancer: a multicenter prospective study.

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OOC-16007907
• Date of registration: 2016-02-06
• Prospective Registration: No
• Primary sponsor: Enshi Tujia and Miao Autonomous Prefecture Central Hospital
• Public title: IL-6/STAT3 for prediction of response after neoadjuvant chemoradiation therapy for stages II-III rectal cancer: a multicenter prospective study.
• Scientific title: IL-6/STAT for prediction of response after neoadjuvant chemoradiation therapy for stages II-III rectal cancer: a multicenter prospective study.
• Date of first enrolment: 2016-02-05
• Target sample size: Experimental group:100;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=13358
• Study type: Observational study
• Study design: Case series
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Qiang Liu
• Affiliation: Enshi Tujia and Miao Autonomous Prefecture Central Hospital

• Name: Chuying Huang

Key inclusion & exclusion criteria

Inclusion criteria: 1. patients with histologically proven adenocarcinoma of the rectum, stages II-III;
2. Eastern Co-operative Oncology Group score is between 0-2;
3. Aged from 18 to 75 years old;
4. ANC>1.5*10^9/L, PLT>100*10^9/L, Hb>9.0g/dl, BIL Colorectal Cancerat normal level or < 1.5*ULN, AST (SGOT), ALT (SGPT) < 2.5*ULN; SCr< 1.5*ULN;
5. Signed informed consent.
Exclusion criteria: 1. Pregnant or lactating women;
2. psychotic patient;
3. Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy;
4. Immune dysfunction , such as HIVaplastic anemialeukemiaetc;
5. using other experimental drugs or paticipate in other clinical trials at the same time.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

rectal cancer

Intervention(s)

Experimental group:Intervention: Eligible patients received pelvic radiotherapy with a dose of 46 Gy, tumor boost of 50Gy over a period of 5 weeks. Patients were given choices between capecitabine 1500 mg/m2 twice daily d1-14 or intravenous bolus 5-FU (400 mg/m2 daily injection for 4 days) and leucovorin (20 mg/m2 daily);

Primary Outcome(s)

Pathological downstaging rate;Ro resection rate;Sphincter preserving rate;Surgical complication;

Secondary Outcome(s)

5-year disease free survival;5-year overall survival;

Source(s) of Monetary Support

self-collect