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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:

histologically verified adenocarcinoma of the rectum;
the lower border of the tumor within 12cm of the anal verge;
age between 18 to 80 years;
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);
ECOS ≤ 2
there was no evidence of metastasis with chest and abdominopelvic CT.

Exclusion Criteria:

with other colorectal cancer, or other cancer,simultaneously;
Locally recurrent rectal cancer;
had a history of malignant tumor within 5 years(except the skin cancer);
Pregnant or lactating women
there was contraindication for the preoperative adjuvant radiotherapy or the operation.
with antitumor drug or radiation before this trial.
discovery of metastasis in the operation
worrying about the local recurrence or the adverse effect of the radiation excessively;
with mental disorder.

Contacts and Locations

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:

Korkolis DP, Plataniotis GD, Gondikakis E, Xinopoulos D, Koulaxouzidis GV, Katsilieris J, Vassilopoulos PP. Short-term preoperative radiotherapy is a safe approach for treatment of locally advanced rectal cancer. Int J Colorectal Dis. 2006 Jan;21(1):1-6. Epub 2005 Jun 10.

Gu J, Wang L. [Standardized examination and research advancement of circumferential resection margin in patients with middle-lower rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2011 Apr;14(4):229-33. Chinese.

Frasson M, Garcia-Granero E, Roda D, Flor-Lorente B, Roselló S, Esclapez P, Faus C, Navarro S, Campos S, Cervantes A. Preoperative chemoradiation may not always be needed for patients with T3 and T2N+ rectal cancer. Cancer. 2011 Jul 15;117(14):3118-25. Epub 2011 Jan 24.

Stephens RJ, Thompson LC, Quirke P, Steele R, Grieve R, Couture J, Griffiths GO, Sebag-Montefiore D. Impact of Short-Course Preoperative Radiotherapy for Rectal Cancer on Patients' Quality of Life: Data From the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 Randomized Clinical Trial. J Clin Oncol. 2010 Jun 28; [Epub ahead of print]

Kav T, Bayraktar Y. How useful is rectal endosonography in the staging of rectal cancer? World J Gastroenterol. 2010 Feb 14;16(6):691-7. Review.

Pietrzak L, Bujko K, Nowacki MP, Kepka L, Oledzki J, Rutkowski A, Szmeja J, Kladny J, Dymecki D, Wieczorek A, Pawlak M, Lesniak T, Kowalska T, Richter P; Polish Colorectal Study Group. Quality of life, anorectal and sexual functions after preoperative radiotherapy for rectal cancer: report of a randomised trial. Radiother Oncol. 2007 Sep;84(3):217-25. Epub 2007 Aug 10.

Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, Rutten H, Pahlman L, Glimelius B, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma. Ann Surg. 2007 Nov;246(5):693-701.

van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Påhlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011 Jun;12(6):575-82. Epub 2011 May 17.

Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. Summary for patients in: Can J Surg. 2003 Feb;46(1):54-6. Med J Aust. 2002 Nov 18;177(10):563-4.

Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20.

[No authors listed] Improved survival with preoperative radiotherapy in resectable rectal cancer. Swedish Rectal Cancer Trial. N Engl J Med. 1997 Apr 3;336(14):980-7. Erratum in: N Engl J Med 1997 May 22;336(21):1539.

Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50.

Birgisson H, Påhlman L, Gunnarsson U, Glimelius B; Swedish Rectal Cancer Trial Group. Adverse effects of preoperative radiation therapy for rectal cancer: long-term follow-up of the Swedish Rectal Cancer Trial. J Clin Oncol. 2005 Dec 1;23(34):8697-705.

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:

Neoplasms
Rectal 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 May 16, 2013