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

NCT01437514 | Terminated Phase 2 DMC

• 1 other identifier: pSRT-201106
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 4

Brief Summary

The local recurrence of rectal cancer is one of the main problem that fail the treatment. The preoperative neoadjuvant (chemo)radiotherapy has been confirmed to reduce the local recurrence rate,especially in the advanced rectal cancer. However the local recurrence rate is low about 10-20% totally,and the integrity of the mesorectum after the operation and circumferential resection margin(CRM) are the most critical factor for the local recurrence.So that, the advanced rectal cancer patients with negative CRM and had a complete mesorectum excision,may not benefit from the neoadjuvant radiation.This trial was mainly focus on the resectable advanced rectal cancer patients whose preoperative stage was cT3/N+. These patients will be divided into the lower risk group and higher risk group according the preoperative CT,Endoscopic ultrasound, and MRI,and carrying out randomized trial in the two groups respectively.The purpose of this trial is to confirm whether the preoperative radiotherapy is necessary for all the advanced rectal cancer patients,identify the reason of the local recurrence,and finally help the making of the treatment decision for the advanced resectable rectal cancer.

Conditions

Rectal Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• local recurrence

  3 years

Secondary Outcomes (5)

• disease free survival

  3 years

• metastatic rate

  3 years

• quality of life

  3 years

• overall survival

  3 years

• short-term complication of the surgery

  first 30 day after operation

Study Arms (4)

lower risk group with pSRT

EXPERIMENTAL

the patients that was divided into the lower risk group that the mesorectum involvement less than 5mm, and no lymph node larger than 8mm according to the preoperative CT, MRI and Endosonography,and these patients accept the preoperative short-course radiotherapy before the surgery

Radiation: preoperative short-course radiotherapy

lower risk group with operation only

NO INTERVENTION

the patients that was divided into the lower risk group that the mesorectum involvement less than 5mm, and no lymph node larger than 8mm,according to the preoperative CT, MRI and Endosonography,and these patients have a operation directly without preoperative radiotherapy.

higher risk group with pSRT

EXPERIMENTAL

the patients that was divided into the higher risk group that the mesorectum involvement more than 5mm, or with lymph node larger than 8mm according to the preoperative CT, MRI and Endosonography,and these patients have a operation directly without preoperative radiotherapy.these patients have the preoperative short-course radiotherapy before the surgery.

Radiation: preoperative short-course radiotherapy

higher risk group with operation directly

NO INTERVENTION

the patients that was divided into the higher risk group that the mesorectum involvement more than 5mm, or with lymph node larger than 8mm according to the preoperative CT, MRI and Endosonography,and these patients have a operation directly without preoperative radiotherapy.

Interventions

preoperative short-course radiotherapy RADIATION

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.

Also known as: short term regimen of high-dose preoperative radiotherapy (5×5 Gy), preoperative short term radiotherapy

higher risk group with pSRT; lower risk group with pSRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically verified adenocarcinoma of the rectum;
• the lower border of the tumor within 10cm of the anal verge;
• age between 18 to 80 years;
• preoperative endosonography,MRI and the abdominopelvic CT diagnosis as advanced rectal cancer (cT3/N+)(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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (4)

Sichuan academy of medical science and sichuan provincial people's hospictal

Chengdu, Sichuan, 610000, China

Location

the Third People'S Hospital of Chengdu

Chengdu, Sichuan, 610000, China

Location

West China hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

The Third Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Related Publications (14)

• 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. doi: 10.1007/s00384-005-0740-7. Epub 2005 Jun 10.

  PMID: 15947936 BACKGROUND

• 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.

  PMID: 21538262 BACKGROUND

• Frasson M, Garcia-Granero E, Roda D, Flor-Lorente B, Rosello 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. doi: 10.1002/cncr.25866. Epub 2011 Jan 24.

  PMID: 21264832 BACKGROUND

• 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 Sep 20;28(27):4233-9. doi: 10.1200/JCO.2009.26.5264. Epub 2010 Jun 28.

  PMID: 20585099 BACKGROUND

• 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. doi: 10.3748/wjg.v16.i6.691.

  PMID: 20135716 BACKGROUND

• 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. doi: 10.1016/j.radonc.2007.07.007. Epub 2007 Aug 10.

  PMID: 17692977 BACKGROUND

• 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. doi: 10.1097/01.sla.0000257358.56863.ce.

  PMID: 17968156 BACKGROUND

• van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Pahlman 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. doi: 10.1016/S1470-2045(11)70097-3. Epub 2011 May 17.

  PMID: 21596621 BACKGROUND

• 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. doi: 10.1056/NEJMoa010580.

  PMID: 11547717 BACKGROUND

• 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. doi: 10.1016/S0140-6736(09)60484-0.

  PMID: 19269519 BACKGROUND

• Swedish Rectal Cancer Trial; Cedermark B, Dahlberg M, Glimelius B, Pahlman L, Rutqvist LE, Wilking N. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997 Apr 3;336(14):980-7. doi: 10.1056/NEJM199704033361402.

  PMID: 9091798 BACKGROUND

• 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. doi: 10.1200/JCO.2005.08.144.

  PMID: 16110023 BACKGROUND

• Birgisson H, Pahlman 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. doi: 10.1200/JCO.2005.02.9017.

  PMID: 16314629 BACKGROUND

• Deng X, Liu P, Jiang D, Wei M, Wang X, Yang X, Zhang Y, Wu B, Liu Y, Qiu M, Zhuang H, Zhou Z, Li Y, Xu F, Wang Z. Neoadjuvant Radiotherapy Versus Surgery Alone for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors: A Prospective Multicenter Stratified Randomized Trial. Ann Surg. 2020 Dec;272(6):1060-1069. doi: 10.1097/SLA.0000000000003649.

  PMID: 31599809 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor of the West China Hospital, Sichuan University

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 21, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

CN (4)