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Related Experiment Video

Updated: Feb 24, 2026

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Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Interim Results from a Randomized Trial.

Ravi Shankar Biswas1, Sulagna Das2, Dipankar Ray1

  • 1Department of Surgical Gastroenterology, Medical College Hospital, Kolkata, West Bengal India.

Indian Journal of Surgical Oncology
|February 23, 2026
PubMed
Summary

Total neoadjuvant therapy (TNT) shows promise for locally advanced rectal cancer (LARC) by significantly reducing distant metastasis compared to conventional chemoradiotherapy (CRT). While pathological complete response rates were similar, TNT may improve long-term outcomes.

Keywords:
LARCRectal cancerTotal neoadjuvant therapy

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Area of Science:

  • Oncology
  • Surgical Oncology
  • Gastrointestinal Oncology

Background:

  • Locally advanced rectal cancer (LARC) presents treatment challenges with conventional chemoradiotherapy (CRT).
  • Poor pathological complete response (pCR) and high rates of distant metastasis are common with standard CRT.
  • Total neoadjuvant therapy (TNT) is emerging as a strategy to improve outcomes in LARC.

Purpose of the Study:

  • To compare the efficacy and safety of TNT versus conventional CRT in LARC patients.
  • To evaluate the impact of TNT on achieving pCR and reducing distant metastasis.
  • To assess secondary endpoints including tumor regression and margin status.

Main Methods:

  • An open-labelled randomized controlled trial involving 172 LARC patients.
  • Arm A (TNT): Preoperative CRT followed by three cycles of CapOx chemotherapy.
  • Arm B (CRT): Preoperative CRT followed by six cycles of adjuvant CapOx chemotherapy.

Main Results:

  • Interim analysis of 150 patients showed comparable pCR rates (16.2% vs. 17.4%; p>0.05).
  • The TNT group demonstrated significantly fewer distant metastasis cases at 1 year (6 vs. 16; p=0.040).
  • No significant differences were observed in tumor regression, margin status, or toxicity.

Conclusions:

  • TNT and conventional CRT yield similar pCR rates in LARC.
  • TNT significantly reduces distant metastasis at one year, suggesting improved systemic control.
  • TNT is a potential preferred treatment strategy for LARC, pending further long-term follow-up.