Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients

NCT06043999 | Recruiting

• 1 other identifier: GIH-SCTVTMEFLR
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

Whether to perform radical TME or salvage chemoradiotherapy after local resection of intermediate-risk T1 rectal cancer is still controversial. A study based on the National Cancer Data Center showed that, because of the need for organ preservation, rescue chemoradiotherapy after local resection of rectal cancer was used in 10% of patients with T1N0 tumors and in 40% of patients with T2N0 tumors. However, the local recurrence caused by non-TME surgery is still the focus of concern for clinicians and patients. Previous retrospective studies have shown that there is no significant difference in overall survival and disease free survival between salvage CRT group and salvage TME group for patients with early rectal cancer after local resection. Pathological pT2 after local resection is the only independent risk factor for disease-free survival. However, limited to a single center and small sample size, the recurrence caused by salvage radiotherapy and chemotherapy should still be alert. Given these concerns, there is an urgent need to identify a better treatment regimen that can ensure reliable oncologic outcomes after local resection. Therefore, with TME as the control group and salvage chemoradiotherapy as the experimental group, we conducted a prospective, randomized, multicenter, non-inferiority clinical trial of the treatment effect of patients with intermediate-risk T1 and clinical stage N0M0 rectal cancer after local resection, to provide high-level evidence-based medical evidence for the final choice of these two salvage treatment methods.

Conditions

Chemotherapy Effect; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Three years disease-free survival rate

  Disease-free survival was defined as the absence of clinical, radiologic, or pathological (consistent with the pathological type of the primary tumor) evidence of recurrence on systemic examination, colonoscopy, CT/MRI, PET-CT, or needle biopsy (if necessary)

  3 years after intervention

Secondary Outcomes (8)

• Three years local recurrence rate

  3 years after intervention

• Three years overall survival rate

  3 years after intervention

• Five years disease-free survival

  5 years after intervention

• five years overall survival

  5 years after intervention

• Anal function

  up to 24 weeks year after intervention

Study Arms (2)

Salvage adjuvant chemoradiotherapy group

EXPERIMENTAL

Patitents under local radical resection of rectal adenocarcinoma received: 1. Concurrent adjuvant chemotherapy 2. Adjuvant radiotherapy: long-course radiotherapy was planned in this study.

Other: Salavge Adjuvant Chemoradiotherapy

Radical TME group

ACTIVE COMPARATOR

Patitents under local radical resection of rectal adenocarcinoma received: Standard TME surgery was performed 3-4 weeks after local resection.

Procedure: Radical total mesorectal excision

Interventions

Radical total mesorectal excision PROCEDURE

Standard TME surgery was performed 3-4 weeks after local resection. The operation is roughly divided into the following steps:After abdominal exploration, gradually ligation and from the inferior mesenteric vessels, pay attention to protect the left ureter, reproductive blood vessels and upper abdominal nerve; The descending colon was fully mobilized and the splenic flexure was mobilized if necessary. Follow the principle of TME, perform sharp resection of the total mesorectum, and pay attention to the protection of the prostate, vagina, pelvic nerve, etc.For can be removed through double stapling technique in low former (LAR) need not inline sphincter resection (excluding cases), to must be inline sphincter resection can be turned to the anus operation (ditto), consistent way can choose according to the intraoperative situation drag anastomosis or manual suture or stapling anastomosis. Prophylactic loop colostomy of transverse colon or ileostomy is recommended.

Radical TME group

Salavge Adjuvant Chemoradiotherapy OTHER

Concurrent adjuvant chemotherapy:5-Fu or 5-Fu analogues based chemotherapy regimens were selected. CapeOx or capecitabine monotherapy or FOLFOX is recommended, and no more than 3 months.Adjuvant radiotherapy protocol:long-course radiotherapy protocol.a. Target definition: areas at high risk for recurrence of the primary tumor and regional lymphatic drainage.b. Radiotherapy technology: conventional radiotherapy, three-dimensional conformal radiotherapy, intensity modulated radiotherapy, image guided radiotherapy, etc.c. Radiation dose:DT of 45Gy,1.8Gy per fraction in 25 fractions, was recommended for the high-risk recurrence area of the primary tumor and the regional lymphatic drainage area.

Salvage adjuvant chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-75 years;
• Local radical resection of rectal adenocarcinoma (TEM, TAMIS, TSPM, EMR, ESD or polypectomy)
• pT1 with a diameter of 3-5 cm, or a maximum diameter of 3 cm, and at least poor differentiation and/or lymphovascular invasion and/or perineural invasion and/or SM3;
• The distance from the lower edge of the tumor to the anal verge was within 10cm on MRI at initial diagnosis;
• clinical stage N0M0 at initial diagnosis;
• no multiple colorectal cancer;
• The heart, lung, liver and kidney function can tolerate surgery;
• Patients and their families were able to understand and willing to participate in this study, and provided written informed consent

You may not qualify if:

• complicated with other malignant tumors or a previous history of malignant tumors;
• not suitable for subsequent chemoradiotherapy or surgery;
• a history of inflammatory bowl disease (IBD) or familial adenomatous polyposis (FAP);
• recently diagnosed with other malignant tumors;
• ASA physical status ≥ IV and/or ECOG performance status \> 2 points;
• patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery;
• a history of severe mental illness;
• pregnant or lactating women;
• Patients with other clinical or laboratory conditions were not considered to be eligible for the study

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (12)

• Wallner C, Lange MM, Bonsing BA, Maas CP, Wallace CN, Dabhoiwala NF, Rutten HJ, Lamers WH, Deruiter MC, van de Velde CJ; Cooperative Clinical Investigators of the Dutch Total Mesorectal Excision Trial. Causes of fecal and urinary incontinence after total mesorectal excision for rectal cancer based on cadaveric surgery: a study from the Cooperative Clinical Investigators of the Dutch total mesorectal excision trial. J Clin Oncol. 2008 Sep 20;26(27):4466-72. doi: 10.1200/JCO.2008.17.3062.

  PMID: 18802159 BACKGROUND

• den Dulk M, Smit M, Peeters KC, Kranenbarg EM, Rutten HJ, Wiggers T, Putter H, van de Velde CJ; Dutch Colorectal Cancer Group. A multivariate analysis of limiting factors for stoma reversal in patients with rectal cancer entered into the total mesorectal excision (TME) trial: a retrospective study. Lancet Oncol. 2007 Apr;8(4):297-303. doi: 10.1016/S1470-2045(07)70047-5.

  PMID: 17395102 BACKGROUND

• Marr R, Birbeck K, Garvican J, Macklin CP, Tiffin NJ, Parsons WJ, Dixon MF, Mapstone NP, Sebag-Montefiore D, Scott N, Johnston D, Sagar P, Finan P, Quirke P. The modern abdominoperineal excision: the next challenge after total mesorectal excision. Ann Surg. 2005 Jul;242(1):74-82. doi: 10.1097/01.sla.0000167926.60908.15.

  PMID: 15973104 BACKGROUND

• Bach SP, Hill J, Monson JR, Simson JN, Lane L, Merrie A, Warren B, Mortensen NJ; Association of Coloproctology of Great Britain and Ireland Transanal Endoscopic Microsurgery (TEM) Collaboration. A predictive model for local recurrence after transanal endoscopic microsurgery for rectal cancer. Br J Surg. 2009 Mar;96(3):280-90. doi: 10.1002/bjs.6456.

  PMID: 19224520 BACKGROUND

• Bosch SL, Teerenstra S, de Wilt JH, Cunningham C, Nagtegaal ID. Predicting lymph node metastasis in pT1 colorectal cancer: a systematic review of risk factors providing rationale for therapy decisions. Endoscopy. 2013 Oct;45(10):827-34. doi: 10.1055/s-0033-1344238. Epub 2013 Jul 24.

  PMID: 23884793 BACKGROUND

• Diagnosis And Treatment Guidelines For Colorectal Cancer Working Group CSOCOC. Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines for colorectal cancer 2018 (English version). Chin J Cancer Res. 2019 Feb;31(1):117-134. doi: 10.21147/j.issn.1000-9604.2019.01.07. No abstract available.

  PMID: 30996570 BACKGROUND

• Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15.

  PMID: 31203527 BACKGROUND

• Min BS, Kim NK, Ko YT, Lee KY, Baek SH, Cho CH, Sohn SK. Long-term oncologic results of patients with distal rectal cancer treated by local excision with or without adjuvant treatment. Int J Colorectal Dis. 2007 Nov;22(11):1325-30. doi: 10.1007/s00384-007-0339-2. Epub 2007 Jun 12.

  PMID: 17571241 BACKGROUND

• Morino M, Allaix ME, Caldart M, Scozzari G, Arezzo A. Risk factors for recurrence after transanal endoscopic microsurgery for rectal malignant neoplasm. Surg Endosc. 2011 Nov;25(11):3683-90. doi: 10.1007/s00464-011-1777-z. Epub 2011 Jun 7.

  PMID: 21647814 BACKGROUND

• Sun G, Tang Y, Li X, Meng J, Liang G. Analysis of 116 cases of rectal cancer treated by transanal local excision. World J Surg Oncol. 2014 Jul 9;12:202. doi: 10.1186/1477-7819-12-202.

  PMID: 25008129 BACKGROUND

• Duek SD, Issa N, Hershko DD, Krausz MM. Outcome of transanal endoscopic microsurgery and adjuvant radiotherapy in patients with T2 rectal cancer. Dis Colon Rectum. 2008 Apr;51(4):379-84; discussion 384. doi: 10.1007/s10350-007-9164-5. Epub 2008 Jan 31.

  PMID: 18236108 BACKGROUND

• Li Y, Qiu X, Shi W, Lin G. Adjuvant chemoradiotherapy versus radical surgery after transanal endoscopic microsurgery for intermediate pathological risk early rectal cancer: A single-center experience with long-term surveillance. Surgery. 2022 Apr;171(4):882-889. doi: 10.1016/j.surg.2021.08.044. Epub 2021 Oct 13.

  PMID: 34656357 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

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

Central Study Contacts

Liang Huang, phD

CONTACT

15989101216; huangl75@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)