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

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ClinicalTrials.gov Identifier: NCT02195141
Recruitment Status : Unknown
Verified February 2015 by Hua Ren, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : July 21, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hua Ren, Chinese Academy of Medical Sciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Radiation: conventional fraction Radiation: SIB Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: conventional fraction
Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily
 Radiation: conventional fraction
capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
Experimental: 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
 Radiation: 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


Outcome Measures
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Primary Outcome Measures :
  1. • Pathological complete remission rate (pCR) [ Time Frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation) ]

Secondary Outcome Measures :
  1. Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) [ Time Frame: during preoperative treatment and after surgery for 5 years ]
    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)


Other Outcome Measures:
  1. • Disease-free survival [ Time Frame: 3 year afte concurrent chemoradiation ]
    Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195141


Contacts
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Contact: Jing Jin, Professor 87788280 jingjin1025@163.com
Contact: Hua Ren, Attending 87788122 renhua2009@hotmail.com

Locations
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China
Cancer Hospital, CAMS Recruiting
Beijing, China, 100021
Contact: Jing Jin, professor    87788200    jingjin1025@163.com   
Contact: Hua Ren, attending    87788122    renhua2009@hotmail.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Chair: Jing Jin, proffessor Dept of Radiation oncology, Cancer hospital, CAMS
More Information
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Responsible Party: Hua Ren, Attending physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02195141    
Other Study ID Numbers: NCC2014-ST02
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Hua Ren, Chinese Academy of Medical Sciences:
Preoperative Chemoradiotherapy
Locally Advanced Rectal Cancer
boost
IMRT
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases