Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Rectal Cancer Clinical Trial

Official title:

Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02195141
• Other study ID #: NCC2014-ST02
• Status: Recruiting
• Phase: Phase 2
• First received: July 11, 2014
• Last updated: February 2, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Jin, Professor
• Phone: 87788280
• Email: jingjin1025[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge

• the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound

Exclusion Criteria:

• metastatic disease

• Eastern Cooperative Oncology Group (ECOG) performance status > 3

• patients not deemed fit for radiotherapy, capecitabine or surgery

• pregnant or lactating patients

• women with child bearing potential who lack effective contraception

• patients below 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Radiation:
• conventional fraction
capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
• SIB
Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily

Locations

Country	Name	City	State
China	Cancer Hospital, CAMS	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• Disease-free survival	Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.	3 year afte concurrent chemoradiation	No
Primary	• Pathological complete remission rate (pCR)		after pathological examination of surgical speciments (6-8 weeks after chemoradiation)	No
Secondary	Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)	Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)	during preoperative treatment and after surgery for 5 years	Yes