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Simple Summary: An international multicenter randomized trial in 174 patients with T3-4 rectal cancer was conducted by the RectumSIB consortium (located at UZ Brussel-VUB in Brussels, Belgium). In this trial, they compared standard 5FU-chemoradiotherapy (CRT) and radiotherapy with a simultaneous integrated boost (SIB) without concomitant chemotherapy in a non-inferiority design. The primary endpoint (metabolic response rate) and secondary endpoints (local control, progression-free survival, survival, pathological response and acute/late toxicity) revealed the equivalence of both treatments. Radiotherapy with an SIB is an appealing treatment strategy for patients with T3-4 rectal cancer that are too frail for chemotherapy. Background: Preoperative chemoradiotherapy (CRT) is the standard treatment for T3-4 rectal cancer. Here, we compared image-guided and intensity-modulated RT (IG-IMRT) with a simultaneous integrated boost (SIB) (instead of concomitant chemotherapy) versus CRT in a multi-centric randomized trial. Methods: cT3-4 rectal cancer patients were randomly assigned to receive preoperative IG-IMRT 46 Gy/23 fractions plus capecitabine 825 mg/m² twice daily (CRT arm) or IG-IMRT 46 Gy/23 fractions with an SIB to the rectal tumor up to a total dose of 55.2 Gy (RTSIB arm). Results: A total of 174 patients were randomly assigned between April 2010 and May 2014. Grade 3 acute toxicities were 6% and 4% in the CRT and RTSIB arms, respectively. The mean fractional change in SUVmax at 5 weeks after completion of preoperative RT were −55.8% (±24.0%) and −52.9% (±21.6%) for patients in the CRT arm and RTSIB arm, respectively (p = 0.43). The pathologic complete response rate was 24% with CRT compared to 14% with RTSIB. There were no differences in 5-year overall survival (OS), progression-free survival (PFS) or local control (LC). Conclusions: The preoperative RTSIB approach was not inferior to CRT in terms of metabolic response, toxicity, OS, PFS and LC, and could be considered an available option for patients unfit for fluorouracil-based CRT. [ABSTRACT FROM AUTHOR]

Simple Summary: Stereotactic body radiotherapy (SBRT) is a recognized treatment for liver or lung metastases, but radiosensitivity of colorectal cancer could be lower than other primary cancers. We postulated that local responses could be improved by SBRT with a concomitant radiosensitizing agent (irinotecan). RADIOSTEREO-CAMPTO was a prospective multi-center phase 2 trial conducted between 2008 and 2013. We confirmed that SBRT-Irinotecan was a short, effective and well-tolerated treatment, with no worsening of the quality of life. It allowed for several months of chemotherapy-free periods despite most patients receiving multiple prior lines of treatment. Radiosensitizing irinotecan was able to compensate for lower SBRT dose than nowadays used for liver and lung metastases and could be an interesting regimen in case of tumour-surrounding healthy tissues requiring limited radiation dose. Background: Stereotactic body radiotherapy (SBRT) is a recognized treatment for colorectal cancer (CRC) metastases. We postulated that local responses could be improved by SBRT with a concomitant radiosensitizing agent (irinotecan). Methods: RADIOSTEREO-CAMPTO was a prospective multi-center phase 2 trial investigating SBRT (40–48 Gy in 4 fractions) for liver and/or lung inoperable CRC oligometastases (≤3), combined with two weekly intravenous infusions of 40 mg/m2 Irinotecan. Primary outcome was the objective local response rate as per RECIST. Secondary outcomes were early and late toxicities, EORTC QLQ-C30 quality of life, local control and overall survival. Results: Forty-four patients with 51 lesions (liver = 39, lungs = 12) were included. Median age was 69 years (46–84); 37 patients (84%) had received at least two prior chemotherapy treatments. Median follow-up was 48.9 months. One patient with two lung lesions was lost during follow-up. Assuming maximum bias hypothesis, the objective local response rate in ITT was 86.3% (44/51—95% CI: [76.8–95.7]) or 82.4% (42/51—95% CI: [71.9–92.8]). The observed local response rate was 85.7% (42/49—95% CI: [75.9–95.5]). The 1 and 2-year local (distant) progression-free survivals were 84.2% (38.4%) and 67.4% (21.3%), respectively. The 1 and 2-year overall survivals were 97.5% and 75.5%. There were no severe acute or late reactions. The EORTC questionnaire scores did not significantly worsen during or after treatment. Conclusions: SBRT with irinotecan was well tolerated with promising results despite heavily pretreated patients. [ABSTRACT FROM AUTHOR]