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Use of circulating tumour DNA (ctDNA) results to inform the decision for adjuvant chemotherapy in patients with locally advanced rectal cancer who have been treated with pre-operative chemo-radiation and surgery.

ABSTRACT: Interventions: The study involves blood collection for ctDNA analysis in patients with locally advanced rectal cancer who have undergone pre-operative long course chemo-radiation and surgery. Two ctDNA samples are collected initially in the outpatient setting; at weeks 4 and 7 post surgery. Patients are then randomised to either the standard of care (SOC) arm or the ctDNA-informed arm. ctDNA-informed arm: Patients who have either a positive ctDNA result OR a negative ctDNA result and have a tumour that is at high-risk of recurring (based on the standard pathology risk assessment of their tumour) will go on to have chemotherapy which will consist of 4 months of either 5FU or Capecitabine with or without Oxaliplatin. Up to a total of five ctDNA blood samples will be collected from each patient during (monthly) and at completion of chemotherapy. SOC arm; A decision regarding adjuvant chemotherapy will be based on the standard pathology risk assessment of their tumour. Chemotherapy will consist of 4 months of treatment with either 5FU or Capecitabine with or without Oxaliplatin. No further ctDNA samples will be collected in this group of patients. All patients will be follow up in the outpatient setting every 3 months for the first 2 years then every 6 months for 3 years out to 5 years in total. In the follow up period, a blood test for CEA (carcinoembryonic antigen; a tumour marker) will be collected at each visit. A CT scan will be done every 6 months for the first 2 years then at 3 years and thereafter only if clinically indicated. Primary outcome(s): To evaluate whether an adjuvant therapy strategy based on ctDNA results in addition to standard pathologic risk assessment may affect the number of patients treated with chemotherapy.[Patients from both Arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Locally Advanced Rectal Cancer Treated With Pre-operative Long Course Chemo-radiation And Surgery,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2466323 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: This design incorporates two separate clinical objectives; (i) non-inferiority and (ii) benefit. This prospective multi-centre, phase II/III randomised study aims to enrol a total of 1000 stage III colon cancer patients. Patients will be randomised 1:1 to be treated according to post-op ctDNA results (Arm B: ctDNA-informed), or per standard of care (Arm A: SOC). Enrolment will be stratified by participating centre and clinical risk groups (low risk = T1-3N1; high risk = T4 and/or N2). Patients should be screened up to 6 weeks after surgery and tumour samples will be made available in 5 working days from consent for mutation analysis. Patients will have a blood draw during week 5-6 post-op for ctDNA analysis (ctDNA-1: post-op day 32 to day 42). Clinicians are to nominate their standard of care adjuvant chemotherapy regimen (no chemotherapy, single agent fluoropyrimidine or combination fluropyrimidine plus oxaliplatin) at the time of enrolment prior to randomisation. Randomisation will occur after the post-op ctDNA blood draw and receipt of sufficient tumour tissue. Additional blood collection time-points will depend on the schedule of adjuvant chemotherapy. Formalin-fixed paraffin embedded tumour tissue and the study bloods sample will undergo ctDNA analysis at Johns Hopkins University. In the ctDNA-informed arm (Arm B), the post-op ctDNA result will be made available to the treating clinician approx 4-5 weeks after receipt of tumour tissue. Adjuvant chemotherapy will commence after the ctDNA result becomes available or, where the treating clinician wishes to commence adjuvant treatment before the result is available, an individual patient may commence on standard of care treatment no earlier than 6 weeks post-op, and then switch to the ctDNA informed Primary Objective - To evaluate the impact of de-escalation/escalation treatment strategies as informed by post-op ctDNA analysis. The ctDNA positive and negative cohorts will be evaluated separately: a.For ctDNA negative patients, the trial will evaluate that a de-escalation treatment strategy is non-inferior to standard of care treatment as measured by the rate of 3-year recurrence-free survival. b.For the ctDNA positive patients, the trial will investigate if an escalation treatment strategy is superior to standard of care treatment as measured by the 24 month recurrence-free survival [Patients from all arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for recurrence. Recurrence-free survival at 3 years post randomisation is measured by the time interval between randomisation and date of first recurrence. Recurrence is defined as evidence of disease either locally or distantly. Clinical assessment, radiological work-up and histological confirmation of recurrent disease will prove the presence of recurrent disease .] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

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Use of circulating tumour DNA (ctDNA) results to inform the decision for adjuvant chemotherapy in patients with locally advanced rectal cancer who have been treated with pre-operative chemo-radiation and surgery.

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