A Phase III, Multi-institutional Randomised Trial Comparing Neoadjuvant Chemoradiotherapy (NARCT) and Total Neoadjuvant Therapy (TNT) in Patients With T3 (a/b/c) Rectal Cancer
Overview
- Phase
- Phase 3
- Intervention
- Neoadjuvant Chemoradiotherapy
- Conditions
- Rectal Cancer
- Sponsor
- St. James's Hospital, Ireland
- Enrollment
- 100
- Primary Endpoint
- Overall survival
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The gold standard treatment for locally advanced, non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy (NACRT), total mesorectal excision (TME) and adjuvant chemotherapy (AC). The primary goal of treatment is to achieve local disease control, reduce tumour volume and minimise the risk of distant metastases. While this multimodal treatment approach has offered improvements in local control and sphincter preservation, it has had little effect on distant recurrence and overall survival. We aim to compare NACRT and TME using the following endpoints:
Primary -->To compare the effects neoadjuvant chemoradiotherapy versus total neoadjuvant therapy (TNT) for T3 rectal cancer on overall survival.
Secondary --> To compare the effects neoadjuvant chemoradiotherapy (NARCT) and total neoadjuvant therapy (TNT) for cT3 rectal cancer on clinical outcomes:
- Clinical complete response (cCR)
- Pathological complete response (pCR)
- Disease-free survival (DFS)
- Organ preservation
- Overall morbidity / mortality
- Treatment-related morbidity / mortality
- Peri-operative outcomes
Investigators
Michael Kelly
Consultant Colorectal Surgeon
St. James's Hospital, Ireland
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Neoadjuvant chemoradiotherapy
The NARCT regimen is prescribed specifically as standard 5-FU over several weeks. The CRT regimen consists of the standard algorithms: a total of 5400-5600 cGy of radiation (4500 cGy to the pelvis, with an integrated boost to the primary tumour and involved nodes of 500 cGy followed by an option boost to the primary tumour and involved nodes) delivered in 27-28 fractions, respectively, of 180-200 cGy each over a 5-6 week period.
Intervention: Neoadjuvant Chemoradiotherapy
Total Neoadjuvant Therapy
Sequence of TNT regimen can be classified as induction (chemotherapy first) or consolidation (radiation first) treatment. All patients received the same chemotherapy (FOLFOX) and long-course chemoradiotherapy (50.4 Gy in 28 fractions) before surgery. However timing of TNT can differ depending on concerns of local and distal failure.
Intervention: Total Neoadjuvant Therapy
Outcomes
Primary Outcomes
Overall survival
Time Frame: Five years
Alive
Secondary Outcomes
- Clinical complete response(6 months)
- Pathological complete response(6 months)
- Disease-free survival(5 years)
- Progression-free survival(5 years)