Trial record 11 of 275 for:    Open Studies | "Rectal Neoplasms"

Effective Study of Preoperative Short-course Radiotherapy for the Advanced Resectable Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by West China Hospital
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital
ClinicalTrials.gov Identifier:
NCT01437514
First received: September 14, 2011
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

The local recurrence after the radical operation of rectal cancer is the main problem that confusing the doctor and the patients. The preoperative adjuvant chemo-radiotherapy has been confirmed to be effective to reduce the local recurrence rate,especially the advanced resectable rectal cancer. As the invading state of the mesorectum by the tumor and the integrity of the mesorectum after the operation are the most critical factor for the local recurrence. So that, how to select the patients with high risk of local recurrence to have a radiotherapy before the operation, which both reducing the local recurrence rate and decreasing the adverse effect of the radiotherapy, over treatment,and avoiding the waste of the medical resource, became a problem. This trial was mainly focus on the patients whose preoperative stage was T3 or N+. These patients which included will be divided in to 2 subgroup, the early mesorectal involvement group (EMRI) and the late mesorectal involvement group (LMRI) according the preoperative CT and Endoscopic ultrasound,and carrying out randomized trial in the two groups individually.The purpose of this trial is to confirm whether the preoperative radiotherapy is necessary for the EMRI patients,identify the reason of the local recurrence,and finally help the making of the treatment decision for the advanced resectable rectal cancer.


Condition Intervention Phase
Rectal Neoplasms
Radiation: preoperative short-course radiotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: the Effect of the Preoperative Short-course Radiotherapy for the cT3/cN+ Mid-lower Rectal Cancer: a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • local recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    the time from operation to confirmed local recurrence, distant metastases, or death due to disease or treatment, whichever occurred first.

  • metastatic rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    ratio of the patients with metastasis after the operation

  • quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    the fraction of the person from the operation the death,no matter the reason of the death.

  • short-term complication of the surgery [ Time Frame: first 30 day after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: August 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMRI with pSRT
the patients that was divided into the early mesorectal involvement group according to the preoperative CT and Endosonography,and these patients will accept the preoperative short-course radiotherapy before the surgery
Radiation: preoperative short-course radiotherapy
preoperative RT received a total dose of 25 Gy in five fractions during five consecutive days. The clinical target volume included the primary tumor and the mesentery with vascular supply containing the perirectal, presacral, and internal iliac nodes(up to the S1/S2 junction).The recommended upper border was at the level of the promontory. Radiation treatment was delivered with a three-portal technique.
Other Names:
  • short term regimen of high-dose preoperative radiotherapy (5×5 Gy)
  • preoperative short term radiotherapy
No Intervention: EMRI with operation directly
the patients was divided into the early mesorectal involvement group according to the preoperative CT and Endosonography,and these patients will have a operation directly without preoperative radiotherapy.
Experimental: LRMI with pSRT
the patients that was divided into the late mesorectal involvement group according to the preoperative CT and Endosonography,and these patients will have the preoperative short-course radiotherapy before the surgery
Radiation: preoperative short-course radiotherapy
preoperative RT received a total dose of 25 Gy in five fractions during five consecutive days. The clinical target volume included the primary tumor and the mesentery with vascular supply containing the perirectal, presacral, and internal iliac nodes(up to the S1/S2 junction).The recommended upper border was at the level of the promontory. Radiation treatment was delivered with a three-portal technique.
Other Names:
  • short term regimen of high-dose preoperative radiotherapy (5×5 Gy)
  • preoperative short term radiotherapy
No Intervention: LMRI with operation directly
the patients that was divided into the late mesorectal involvement group according to the preoperative CT and Endosonography,and these patients will have operation without preoperative radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histologically verified adenocarcinoma of the rectum;
  2. the lower border of the tumor within 12cm of the anal verge;
  3. age between 18 to 80 years;
  4. preoperative endosonography and the abdominopelvic CT diagnosis as early mesorectal involvement or late mesorectal involvement(the detail of these two subgroup was illustrated in the detailed description of this trial);
  5. ECOS ≤ 2
  6. there was no evidence of metastasis with chest and abdominopelvic CT.

Exclusion Criteria:

  1. with other colorectal cancer, or other cancer,simultaneously;
  2. Locally recurrent rectal cancer;
  3. had a history of malignant tumor within 5 years(except the skin cancer);
  4. Pregnant or lactating women
  5. there was contraindication for the preoperative adjuvant radiotherapy or the operation.
  6. with antitumor drug or radiation before this trial.
  7. discovery of metastasis in the operation
  8. worrying about the local recurrence or the adverse effect of the radiation excessively;
  9. with mental disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437514

Contacts
Contact: Deng Xiang bing +8613730677124 xiangbingdeng@gmail.com
Contact: Zhang yuan chuan +8685474922 dongxibu@gmail.com

Locations
China, Sichuan
West China hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610000
Contact: Wang zi qiang    +86-18980602028    wzqtrial@gmail.com   
Contact: Deng xiang bing    +86-13730677124    xiangbingdeng@gmail.com   
Principal Investigator: Shu ye         
Principal Investigator: Xu feng         
Sichuan academy of medical science and sichuan provincial people's hospictal Recruiting
Chengdu, Sichuan, China, 610000
Contact: Wang Kang, chief surgeon    134455324242    wangkang@gmail.com   
Principal Investigator: Wang Kang, MD         
the Third People'S Hospital of Chengdu Recruiting
Chengdu, Sichuan, China, 610000
Contact: Liu Yan jun, MD    15108402860      
Principal Investigator: Liu Yan jun, MD         
Sponsors and Collaborators
West China Hospital
  More Information

Publications:

Responsible Party: Ziqiang Wang,MD, associated professor of the West China Hospital, Sichuan University, West China Hospital
ClinicalTrials.gov Identifier: NCT01437514     History of Changes
Other Study ID Numbers: pSRT-201106
Study First Received: September 14, 2011
Last Updated: February 22, 2013
Health Authority: China: Ministry of Health

Keywords provided by West China Hospital:
rectal cancer
Endosonography
preoperative short-course radiotherapy
preoperative adjuvant therapy
neoadjuvant therapy
short-term high-dose preoperative radiotherapy
total mesorectal excision
circumferential resection margin
local recurrence
overall survival
metastasis
complication

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014