S20
Brachytherapy - Gastro-intestinal, paediatric brachytherapy, miscellaneous
ESTRO 2026
to its ability to activate Nrf2, which may improve treatment tolerance and outcomes. Material/Methods: Phase-II, double-blind, placebo-controlled trial; randomised non-circumferential, non-mucinous/signet locally-advanced lower-mid rectal cancer patients to either receive CHL(750 mg OD) or placebo, 10-14 days before to 3 months post-TNT. All patients received SCRT (25 Gy/5 fractions with SIB to primary: 27.5Gy and lymph-nodes: 30Gy) followed by 18 weeks of chemotherapy (CAPOX/mFOLFOX/single-agent 5-FU as suitable). MR-based endorectal brachytherapy was interdigated at 8-12 weeks post-SCRT (5-7 Gy X 3-5 #) using two inflatable balloons over indigenously designed 3D-printed six-channel MR-compatible applicator as suitable. The primary objective was to reduce cumulative acute GI/GU/HT >grade 2 CTCAEv5 side effects (70 to 40%). The secondary endpoint of cCR and overall response rates (ORR: cCR+pCR) at 24- 36 weeks post-TNT was statistically powered against historical pCR of 28%(Est 95% CI: 24% - 32%)3. Secondary outcomes of other side effects and grades, 2-year TME free survival, DFS, OS are reported. (CTRI/2023/04/051458, NCT05856305). Funded by BARC, DAE and philanthropy from Mr Sunil K Gupta. Results: Of the 76 patients randomised, 73 initiated treatment (37 with CHL, 36 with Placebo). SCRT, TNT, and brachytherapy were completed by 100%, 89%, and 82% respectively. The cumulative GI/GU/HT grade >2 side effects were significantly less in the CHL arm (unadjusted: 94.4% versus 64.9%; RR=0.69; CI[0.53- 0.88]; p=0.003), adjusted (CT and RT intensity) RR = 0.69; CI[0.54-0.90] p = 0.005). The general characteristics and side effect profile are presented in Table 1.
Figure 1b Conclusion:
Although we are at the beginning of the work, the progress we have made and the preliminary data we have obtained are promising for the development of this new applicator. In upcoming studies, it is planned to produce the prototype compatible with various brachytherapy devices and to conduct in vivo and in vitro dosimetric tests. Keywords: Brachytherapy, Applicator, Rectal Cancer
Proffered Paper 1281
Ph-II double-Blind RCT: SCRT-based TNT & MR-BCT with/without Chlorophyllin (Nrf2 activator) for NOM in locally advanced rectal cancer (SCOTCH study) Rahul Krishnatry 1,2 , Vikram Gota 3 , Reena Engineer 1 , Vikas Ostwal 4 , Mufaddal Khuzema Kazi 5 , Purvi Haria 6 , Aditya Kale 7 , Ashwin Luis Desouza 5 , Avanish Saklani 5 , Anant Ramaswamy 4 , Salma S 8 , Sadhana Kanan 8 , Prabhat Ghanshyam Bhargava 4 , Shivakumar Gudi 1 , Debanjan Chakraborty 1 , Aditi Jain 1 , Sridhar Sundaram 7 , Prachi Patil 7 , Sudeep Gupta 4 1 Radiation Oncology, Tata Memorial Centre (HBNI),, Mumbai, India. 2 HBNI, HBNI University, Mumbai, India. 3 Clinical Pharmacology, Tata Memorial Centre (HBNI),, Mumbai, India. 4 Medical Oncology, Tata Memorial Centre (HBNI),, Mumbai, India. 5 Surgical Oncology, Tata Memorial Centre (HBNI),, Mumbai, India. 6 Radiology, Tata Memorial Centre (HBNI),, Mumbai, India. 7 Medical Gastroenterology, Tata Memorial Centre (HBNI),, Mumbai, India. 8 Biostats, Tata Memorial Centre (HBNI),, Mumbai, India
Purpose/Objective: Despite total neoadjuvant therapy (TNT)1 or
brachytherapy (BCT)2, success for non—operative management (NOM) in locally advanced rectal cancer remains modest. Treatment intensification with combination of two may improve NOM rates, but at the cost of increased side effects. Addition of sodium- copper-chlorophyllin (CHL) has potential cytoprotective and radioprotective effects attributed
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