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Trial record 87 of 1549 for:    rectal cancer

Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

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ClinicalTrials.gov Identifier: NCT02031939
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Zhen-Hai Lu, Sun Yat-sen University

Brief Summary:
Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Advanced Rectal Cancer Drug: Induction and gap chemotherapy (Capecitabine combine with oxaliplatin) Radiation: standard chemoradiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard chemoradiotherapy
Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )
Radiation: standard chemoradiotherapy
All rectal patients in this group will receive standard chemoradiotherapy and surgical resection.

Experimental: induction and gap chemotherapy
induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + standard chemoradiotherapy (Capecitabine 2000mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2)
Drug: Induction and gap chemotherapy (Capecitabine combine with oxaliplatin)
All rectal cancer patients in this group will receive induction, gap chemotherapy(capecitabine combine with oxaliplatin) alone with standard chemoradiotherapy before surgery.
Other Names:
  • Xeloda
  • Eloxatin

Radiation: standard chemoradiotherapy
All rectal patients in this group will receive standard chemoradiotherapy and surgical resection.




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 3 years ]
  2. Disease free survival [ Time Frame: 5 years ]
  3. Respond rate [ Time Frame: One week after surgery ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathological confirmed rectal cancer
  • Clinical stage T3-4 or T any N1
  • No metastasis
  • Distance of tumor is no more than 10cm from anal verge
  • No previous radiotherapy
  • Age ranged from 18 to 70
  • Eastern Cooperative Oncology Group score system 0-1

Exclusion Criteria:

  • Clinical stage T1-2 N0
  • Distance metastasis
  • Multiple primary tumor
  • Cachexy

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): NCT02031939


Contacts
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Contact: Zhen-Hai Lu, Prof. +86 20 87343584 luzhh@sysucc.org.cn
Contact: Rong-Xin Zhang, M.D. +86 20 87343456 zhangrx@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhen-Hai Lu, Prof.    +86 20 87343584    luzhh@sysucc.org.cn   
Contact: Rong-Xin Zhang, M.D.    +86 20 87343456    zhangrx@sysucc.org.cn   
Principal Investigator: Zhen-Hai Lu, Prof.         
Sub-Investigator: Rong-Xin Zhang, M.D.         
Sub-Investigator: Fu-Long Wang, M.D.         
Sub-Investigator: Yuan-Hong Gao, M.D.         
Sub-Investigator: Yu-Jing Fang, PhD.         
Sub-Investigator: Xiao-Jun Wu, M.D.         
Sub-Investigator: Zhi-Zhong Pan, M.D.         
Sub-Investigator: Gong Chen, M.D.         
Sub-Investigator: Pei-Rong Ding, M.D.         
Sub-Investigator: Zhi-Fan Zeng, M.D.         
Sub-Investigator: Jun-Zhong Lin, M.D.         
Sub-Investigator: Qing Liu, M.D.         
Sub-Investigator: De-Sen Wan, Prof.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhen-Hai Lu, Prof. Sun Yat-sen University

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Responsible Party: Zhen-Hai Lu, Pofessor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02031939     History of Changes
Other Study ID Numbers: 2013013
SYSU5010Fund ( Other Grant/Funding Number: Sun Yat-Sen University 5010 Fund )
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Keywords provided by Zhen-Hai Lu, Sun Yat-sen University:
Rectal cancer
neoadjuvant chemoradiotherapy
optimization
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents