Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial).

BACKGROUND: Preoperative (chemo)radiotherapy has been widely used as an effective treatment for locally advanced rectal cancer (LARC), leading to a significant reduction in pelvic recurrence rates. Because early administration of intensive chemotherapy for LARC has more advantages than adjuvant chemotherapy, total neoadjuvant therapy (TNT) has been introduced and evaluated to determine whether it can improve tumor response or treatment outcomes. This study aims to investigate whether short-course radiotherapy (SCRT) followed by intensive chemotherapy improves oncologic outcomes compared with traditional preoperative long-course chemoradiotherapy (CRT). METHODS: A multicenter randomized phase II trial involving 364 patients with LARC (cT3-4, cN+, or presence of extramural vascular invasion) will be conducted. Patients will be randomly assigned to the experimental or control arm at a ratio of 1:1. Participants in the experimental arm will receive SCRT (25 Gy in 5 fractions, daily) followed by four cycles of FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) as a neoadjuvant treatment, and those in the control arm will receive conventional radiotherapy (45-50.4 Gy in 25-28 fractions, 5 times a week) concurrently with capecitabine or 5-fluorouracil. As a mandatory surgical procedure, total mesorectal excision will be performed 2-5 weeks from the last cycle of chemotherapy in the experimental arm and 6-8 weeks after the last day of radiotherapy in the control arm. The primary endpoint is 3-year disease-free survival, and the secondary endpoints are tumor response, overall survival, toxicities, quality of life, and cost-effectiveness. DISCUSSION: This is the first Korean randomized controlled study comparing SCRT-based TNT with traditional preoperative LC-CRT for LARC. The involvement of experienced colorectal surgeons ensures high-quality surgical resection. SCRT followed by FOLFOX chemotherapy is expected to improve disease-free survival compared with CRT, with potential advantages in tumor response, quality of life, and cost-effectiveness. TRIAL REGISTRATION: This trial is registered at Clinical Research Information under the identifier Service KCT0004874 on April 02, 2020, and at Clinicaltrial.gov under the identifier NCT05673772 on January 06, 2023.

Anastomotic Sinus That Developed From Leakage After a Rectal Cancer Resection: Should We Wait for Closure of the Stoma Until the Complete Resolution of the Sinus?

PURPOSE: The aims of this study were to identify the clinical characteristics of an anastomotic sinus and to assess the validity of delaying stoma closure in patients until the complete resolution of an anastomotic sinus. METHODS: The subject patients are those who had undergone a resection of rectal cancer from 2011 to 2017, who had a diversion ileostomy protectively or therapeutically and who developed a sinus as a sequelae of anastomotic leakage. The primary outcomes that were measured were the incidence, management and outcomes of an anastomotic sinus. RESULTS: Of the 876 patients who had undergone a low anterior resection, 14 (1.6%) were found to have had an anastomotic sinus on sigmoidoscopy or a gastrografin enema before their ileostomy closure. In the 14 patients with a sinus, 7 underwent ileostomy closure as scheduled, with a mean closure time of 4.1 months. The remaining 7 patients underwent ileostomy repair, but it was delayed until after the follow-up for the widening of the sinus opening by using digital dilation, with a mean closure time of 6.9 months. Four of those remaining seven patients underwent stoma closure even though their sinus condition had not yet been completely resolved. No pelvic septic complications occurred after closure in any of the 14 patients with an anastomotic sinus, but 2 of the 14 needed a rediversion due to a severe anastomotic stricture. CONCLUSION: Patients with an anastomotic sinus who had been carefully selected underwent successful ileostomy closure without delay.

Clinical significance of primary tumor resection in colorectal cancer patients with synchronous unresectable metastasis.

BACKGROUND: The aim of this study was to compare the outcomes in colorectal cancer (CRC) patients with synchronous unresectable metastases who received either primary tumor resection (PTR) or chemotherapy as the first treatment and to investigate the clinical course of asymptomatic patients who received chemotherapy as the first treatment. METHODS: We retrospectively analyzed 324 CRC patients with synchronous unresectable metastases. Overall survival (OS) was analyzed for the two groups (upfront PTR group [n = 72] vs. upfront chemotherapy group [n = 252]). Surgical morbidity and mortality were recorded. In the asymptomatic patients who received upfront chemotherapy, the incidences of primary tumor-related complications were analyzed. RESULTS: In patients who underwent PTR as the first treatment, the median OS period was superior to those who received upfront chemotherapy (17.2 vs. 13.6 months, P = 0.002). In the PTR group, surgical morbidity and mortality were 11.6% and 1.9%, respectively. Of the 252 asymptomatic patients, the incidence of primary tumor-related complications was 35%. Emergent surgery was ultimately done in 14% of the 252 patients. CONCLUSION: CRC patients with synchronous unresectable metastases who underwent PTR followed by chemotherapy had significantly longer survival times compared to patients who received chemotherapy as the first treatment.