None listed
Conditions
Brief summary
This study aims to investigate the effect of bridge-to-surgery strategy and chemotherapy prior to definitive surgery for patients with obstructing bowel cancer, compared to upfront surgery, on long term outcomes and recurrence. Who is it for? You may be eligible for this study if you are an adult with clinically and/or endoscopically obstructed colon adenocarcinoma, considered potentially resectable with curative intent and suitable for either upfront resection or a bridge-to-resection strategy. Study details Participants will be randomly allocated to undergo a 'Bridge-to-surgery' strategy (either colonic stenting or stomal diversion) with neoadjuvant systemic chemotherapy once effective relief of obstruction obtained, followed by definitive surgery (Intervention group) vs upfront surgical resection (Standard of care group). Data on peritoneal disease recurrence and survival outcomes will be collected. It is hoped that findings from this study will help clinicians and researchers determine the safest and most effective way to manage obstructed bowel cancers at their index presentation.
Interventions
Bridge to surgery strategy (either colonic stenting or stomal diversion) with neoadjuvant systemic chemotherapy once effective relief of obstruction obtained, followed by definitive surgery (Intervention group)
vs upfront surgical resection (Standard of care group)
Allocation of which bridge-to-surgery intervention patients in the BTS arm receive will be at clinical discretion of the treating surgeon based on anatomical location of the tumour.
Neoadjuvant systemic chemotherapy will be FOLFOX for
Bridge to surgery strategy (either colonic stenting or stomal diversion) with neoadjuvant systemic chemotherapy once effective relief of obstruction obtained, followed by definitive surgery (Intervention group) vs upfront surgical resection (Standard of care group) Allocation of which bridge-to-surgery intervention patients in the BTS arm receive will be at clinical discretion of the treating surgeon based on anatomical location of the tumour. Neoadjuvant systemic chemotherapy will be FOLFOX for 6 cycles, each cycle delivered at fortnightly intervals. (Oxaliplatin 85mg/m2 over 120 minutes IV, leucovorin 50mg/m2 IV and 5-fluorouracil 400mg/m2 IV) given fortnightly in Oncology day suite. All patients will be discussed at their hospital's multidisciplinary meeting (MDM) prior to commencing neoadjuvant therapy. Neoadjuvant therapy will be overseen by the patient's Medical Oncologist in conjunction with their treating surgeon. Electronic medical records will be used to regularly review adherence to neoadjuvant therapy or deviation from trial protocol.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants are adults (18 years of age or older) with clinically and/or endoscopically obstructed colon adenocarcinoma, considered potentially resectable with curative intent and suitable for either upfront resection or a bridge-to-resection strategy.
Exclusion criteria
Exclusion criteria include rectal cancer, evidence of diffuse peritoneal carcinomatosis at presentation, unresectable metastatic disease, or contraindications to either treatment strategy.
Outcome results
None listed