Locally Advanced Rectal Cancer
Conditions
Keywords
rectal cancer, total neoadjuvant therapy, induction chemotherapy, consolidation chemotherapy
Brief summary
The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence
Detailed description
International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.
Interventions
6 cycles CAPOX after chemoradiotherapy
OTHERinduction chemotherapy
4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- histologically proven rectal adenocarcinoma * no distant metastases on CT scan (M0 disease) * at least one high risk factor for disease recurrence identified on MR imaging: * T4 tumor (cT4) * N2 disease (cN2) * extramural venous invasion (cEMVI+) * positive lateral lymph nodes * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+) * capacity for informed consent * willingness to attend regular check-ups during and after treatment
Exclusion criteria
history of previous irradiation in the pelvic area * absolute contraindications for MR imaging * distant metastases cannot be reliably excluded * synchronous cancer * chronic inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | 2 weeks after completiton of TNT | The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | after 3 years of follow-up | time from randomization to death |
| Survival without recurrence of the disease | after 3 years of follow-up | time from the end of treatment (in the case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first. |
| Disease free survival | after 3 years of follow-up | the time from the end of treatment (in the case of cCR) or surgery to the recurrence of disease, the onset of new cancer, death from cancer or other causes |
| local control | after 3 years of follow-up | the time from the end of the treatment (in the case of cCR) or surgery to local recurrence |
Countries
Slovenia
Contacts
Primary ContactVaneja Velenik, PhD
Backup ContactMiha Orazem, MD
Outcome results
None listed