Total Neoadjuvant Therapy (TNT) versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Systematic Review and Meta-Analysis.
Shuang Liu, Ting Jiang, Lin Xiao...
https://pubmed.ncbi.nlm.nih.gov/33987952Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05496491
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Led by Larissa University Hospital · Updated on 2024-10-08
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for locally advanced rectal cancer to compare the current standard approach of neoadjuvant chemoradiation followed by surgery and adjuvant chemotherapy with a new strategy that adds consolidation chemotherapy before surgery. The goal is to improve disease control and survival while reducing treatment delays and complications associated with postoperative chemotherapy. This randomized controlled trial addresses concerns about the safety and effectiveness of total neoadjuvant therapy and aims to clarify benefits while keeping treatment schemes consistent. Participants are assigned to one of two groups. The experimental group receives a 5-week standard neoadjuvant chemoradiotherapy, followed by consolidation chemotherapy during the waiting period before surgery, with MRI re-staging at 6 weeks to determine response. Those who do not respond proceed immediately to surgery, while responders continue chemotherapy until surgery at 12 weeks. The control group receives the same chemoradiotherapy followed by surgery timed by MRI response and then adjuvant chemotherapy. Chemotherapy regimens include CAPOX or FOLFOX protocols. Throughout the study, participants undergo regular MRI scans to assess tumor response and receive detailed monitoring of treatment effects and side effects. Researchers measure disease-free survival over three years, complete pathological response, postoperative complications, hospital stay length, readmissions, negative resection margins, overall survival, chemotherapy toxicity, local recurrence, and treatment compliance. The total study duration extends up to three years postoperatively with ongoing evaluations to understand long-term outcomes.
CONDITIONS
Brief Title
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed rectal adenocarcinoma
- Tumor stage cT3, cT4, with threatened circumferential resection margin, positive extramural vascular invasion, or lymph node involvement (≥N1)
- Decision by multidisciplinary tumor board for neoadjuvant treatment
- Tumor located less than 15 cm from the anal verge based on endoscopy or MRI
- Age between 18 and 80 years
- General health status WHO performance 0-1
- No co-morbidities affecting treatment
- Blood counts: neutrophils >1,500/mm3, platelets >100,000/mm3, hemoglobin >10 g/dL
- Normal kidney function with creatinine clearance >50 mL/min
- Signed informed consent
You will not qualify if you...
- Presence of distant metastases
- Non-resectable cancer
- Contraindications to chemotherapy
- Previous pelvic radiotherapy or chemotherapy
- History of inflammatory bowel disease
- History of angina, acute myocardial infarction, or heart failure
- Active sepsis or systemic infection
- Untreated physical or mental disability
- Presence of synchronous malignancy
- Pregnancy or breastfeeding
- Non-compliance with study protocol
- Failure to provide signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Neoadjuvant Chemoradiotherapy
Duration - 5 weeks
Participants receive a 5-week neoadjuvant radiotherapy regimen combined with Capecitabine chemotherapy.
Weekly visits during the 5-week treatment
Consolidation Chemotherapy or Restaging and Surgery
Duration - Up to 12 weeks
6 weeks after chemoradiotherapy, participants undergo MRI re-staging to assess response. Participants with response receive consolidation chemotherapy during the waiting period before surgery lasting up to 12 weeks. Those without response proceed immediately to surgery.
1 MRI re-staging visit and multiple chemotherapy visits depending on response
Surgery
Duration - 1 day
Participants undergo radical surgical resection based on total mesorectal excision (TME) following chemoradiotherapy and chemotherapy.
1 surgical visit
Adjuvant Chemotherapy
Duration - Approximately 24 to 36 weeks
Participants in the control group receive 8 to 12 cycles of adjuvant chemotherapy postoperatively using CAPOX or FOLFOX regimens.
Repeated chemotherapy visits every 3 weeks for 8 to 12 cycles
Postoperative Follow-up
Duration - 3 years
Participants are monitored for postoperative complications, treatment compliance, and survival outcomes for up to 3 years after surgery.
Regular follow-up visits during the 3-year period
Trial Site Locations
Total: 1 location
1
Department of Surgery, University Hospital of Larissa
Larissa, Greece, 41110
Actively Recruiting
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Research Team
K
Konstantinos Perivoliotis, MD
G
George Tzovaras, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Total Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer: A Systematic Review and Meta-analysis.
Anup Kasi, Saqib Abbasi, Shivani Handa...
https://pubmed.ncbi.nlm.nih.gov/33326026Post-Operative Morbidity and Mortality Following Total Neoadjuvant Therapy Versus Conventional Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer.
Philip Sutera, Julia Solomina, Rodney E Wegner...
https://pubmed.ncbi.nlm.nih.gov/32936391Is long interval from neoadjuvant chemoradiotherapy to surgery optimal for rectal cancer in the era of intensity-modulated radiotherapy?: a prospective observational study.
Hui Chang, Wu Jiang, Wei-Jun Ye...
https://pubmed.ncbi.nlm.nih.gov/30288048Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial.
Renu R Bahadoer, Esmée A Dijkstra, Boudewijn van Etten...
https://pubmed.ncbi.nlm.nih.gov/33301740Total neoadjuvant therapy for rectal cancer: Making sense of the results from the RAPIDO and PRODIGE 23 trials.
E F Giunta, G Bregni, A Pretta...
https://pubmed.ncbi.nlm.nih.gov/33798955Playing With Dynamite? A Cautious Assessment of TNT.
Diana D Shi, Harvey J Mamon
https://pubmed.ncbi.nlm.nih.gov/33052753Total neoadjuvant therapy for rectal cancer: An emerging option.
Ethan B Ludmir, Manisha Palta, Christopher G Willett...
https://pubmed.ncbi.nlm.nih.gov/28295220Total Neoadjuvant Therapy in Rectal Cancer: A Systematic Review and Meta-analysis of Treatment Outcomes.
Fausto Petrelli, Francesca Trevisan, Mary Cabiddu...
https://pubmed.ncbi.nlm.nih.gov/31318794Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial.
Thierry Conroy, Jean-François Bosset, Pierre-Luc Etienne...
https://pubmed.ncbi.nlm.nih.gov/33862000