Rectal cancer

The 2022 Neoadjuvant Treatment in Rectal Cancer Idea Generation Workshop

The fifth Idea Generation Workshop was held virtually on 13 May 2022, facilitated by Associate Professor Sam Ngan (Radiation Oncologist) and Dr Deborah Wright (Lower GI Surgeon). This workshop was held in collaboration with TROG Cancer Research. Ideas focused on neoadjuvant treatment in rectal cancer.

Launched in 2019, the Idea Generation Workshop enables us to deliver on our strategic goals to accelerate the pace of discovery and connect researchers. It serves as a platform for embryonic ideas to be developed, to foster collaboration between both researchers and industry, and to future-proof patient treatment options.

Participants were invited to consider the many aspects of the ideas presented, including potential impact, requirements to ensure its success, potential to become AGITG studies and more. They then voted on the level of enthusiasm for each idea, ranking from ‘highly interested’ to ‘no interest’. Finally, participants had to indicate their interest in assisting to refine and improve the proposed studies.

Take a look below at a snapshot of each idea presented on the day.

Idea 1: Presented by Professor John Mariadason

Title: Assessment of GPX2 as a predictive biomarker of chemoradiation response in locally-advanced rectal cancer.

“The protein GPX2 (a protein present in the GI tract – esophagus to colon) – has an important role in detoxification. Tumors that have high expression of this might be less sensitive to radiation and chemotherapy. This retrospective biomarker study will compare pretreatment GPX2 samples with pathological response to chemo-radiotherapy to see if this might be a predictive marker to response.”

Idea 2: Presented by Associate Professor Zee Wan Wong

Title: Optimal Sequencing of Chemotherapy in Total Neoadjuvant Therapy for Rectal Cancer (OSCAR)

“This study will randomise patients into patients who receive long course chemoradiotherapy, followed by surgery; and patients who will receive chemotherapy upfront in induction, followed by long course chemoradiotherapy and then surgery. CTDNA will be used to assess response, with the aim to establish the best sequencing for patients in this study population.”

Idea 3: Presented by Doctor Ankit Jain

Title: Prospective feasibility study for correlation of ct DNA with radiological/ metabolic assessment in locally advanced high risk rectal cancer treated with neoadjuvant induction chemotherapy with triplet mFOLFIRINOX protocol sequenced with long course chemoradiation therapy followed by surgery.

“Poor ctDNA clearance has been shown to predict disease recurrence and overall survival. This study will look at ctDNA clearance specific to patients treated with FOLFIRINOX chemotherapy protocol in rectal cancer.  The hypothesis of this trial is is that complete clearance of ctDNA, radiological response, and low neoadjuvant rectal score may predict patients who can have better disease-free survival in high-risk rectal cancer patients.

“In turn, this may justify use of this toxic chemotherapy regimen in all patients with high-risk features if suitable to receive intensive treatment.”

Idea 4: Presented by Doctor Daren Tan

Title: Radiotherapy Dose escalation.

“This is a multi-phase study, that will investigate the effect that providing an increased dose of radiotherapy +/- neoadjuvant chemotherapy has in patients with low-risk advanced colorectal patients. The rationale for this study is that previous studies have demonstrated a meaningful correlation between response rate and dose escalation of radiotherapy.

“It is hoped that by increasing the dose of radiotherapy, more responses will be achieved leading to less need for surgical intervention (including stoma requirement) and better quality of life. This study will also investigate the toxicity differences between the two treatments, and establish the differences in both clinical response and reporting of toxicity (through adverse events). ”

Idea 5: Presented by Doctor Joseph Kong

Title: Long CRT versus TNT for Locally Advanced Rectal Cancer.

“The study is investigating whether long-course chemoradiotherpy and consolidation therapy will reduce distant recurrence and improve overall survival in patients with locally advanced colorectal cancer. Patients will either receive a long course ChemoRadiotherapy then have surgery (TME) and then receive adjuvant chemotherapy; or long course ChemoRadiotherapy, followed by consolidation therapy with FOLFOX and then surgery.

Idea 6: Presented Doctor Annabel Smith

Title: Total Neoadjuvant Therapy (TNT) with concurrent Anti-VEGF and Anti-PD-1 in high risk locally advanced rectal cancer (Trio-NT study).

“This study will investigate patients with high risk locally advanced colorectal cancer. Patients will receive long course chemoradiotherapy with concurrent immunotherapy (Anti-PD1) and anti-VEGF at set time points, followed by TNT (CAPOX x 4 cycles) – patients will either then go on to “watch and wait” management OR surgery (based off response rate to neoadjuvant therapy).”

“The primary goal of this study is to complete clinical response (cCR)* and opt for watch and wait. Plus the number of patients who proceed to surgery and have a complete pathological response (pCR).

Idea 7: Presented by Doctor Kristin Hsu

Title: Intensifying TNT by intensifying chemotherapy and adding immunotherapy in locally advanced rectal cancer.

“This study is investigating patients with locally advanced rectal cancer eligible to undergo TNT. Patients will either receive Induction Chemotherapy, followed by chemoradiotherapy in combination with immunotherapy; or receive chemoradiotherapy in combination with immunotherapy, and then receive consolidation chemotherapy (4 cycled 5-FU).

“MRI will be used to determine response – and if there is an early response rate, stop TNT early (if a complete response). If no response, TNT is stopped and surgery is performed.

“The aim of the study is to determine whether it is efficacious, safe and feasible to add immunotherapy to TNT as a new treatment strategy in locally advanced rectal cancer.”

Progressing the workshop ideas

Several ideas presented at the workshop are currently being progressed through our research development pathway into research concepts, and when fully developed, will be presented to the Lower GI Working Party.

Upcoming workshops

We look forward to hosting our next Idea Generation Workshop at 9am AEST, Friday 19 May 2023:

Late Stage Colorectal Cancer:

  • Gaps in current knowledge or embryonic ideas for future AGITG-led clinical trials in late stage colorectal cancer are encouraged for submission.
  • Convenors: Associate Professor Cherry Koh and Dr Matthew Burge.
  • Submissions close: Monday 6 April 2023.
  • Find out more and submit an idea
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