Rectal Cancer, Total Neoadjuvant Treatment
Conditions
Keywords
rectal cancer
Brief summary
Short-course radiotherapy followed by consolidation chemotherapy has shown a better response rate when compared to chemoradiotherapy treatment. In addition, recent studies have shown better tolerance with total neoadjuvant treatment, with induction or consolidation chemotherapy. Induction chemotherapy could reduce the size of the tumor, treat micrometastases early and allow treatment to start immediately (avoiding potential delays in waiting for radiotherapy). While consolidation chemotherapy allows longer waiting times for surgery, with higher response rates.
Detailed description
Methods: This trial aim to evaluate induction treatment with CAPOX, followed by short-course radiotherapy consolidation chemotherapy with CAPOX. After 5-7 weeks, patients will be evaluate by MRI. Patients with incomplete clinical response will be referred to immediate surgery and patients with complete clinical response will be managed with watch and wait approach. Patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment. The sample size was calculated according to Simon's optimal two-stage design. Accordingly, 21 patients must be included in each group during the first stage and 24 during the second stage. Treatment regimen will be considered effective if 9 or more patients show good response (final analysis), reaching 80% power with an alpha of 0.10 level of significance.
Interventions
OTHERApproach
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
Sponsors
Instituto Nacional de Cancer, Brazil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of mid or low rectum * Locally advanced rectal cancer with one of the high-risk factors confirmed by high-resolution thin-slice Magnetic resonance image (3 mm) tumors extending to within 1 mm of, or beyond the mesorectal fascia; tumor extending 5 mm or more into perirectal fat; resectable cT4 tumors; lower third; nodal involvement; extramural vascular invasion * ECOG performance status of 0-2 * An informed consent has been signed by the patient
Exclusion criteria
* Upper rectal cancer * Metastatic disease * The patient received any previous therapy for colorectal cancer or another malignancy * Other malignant tumours within the last 5 years except cervical carcinoma in situ and basal cell carcinoma of the skin * Previous thromboembolic or haemorrhagic events within 6 months prior to registration * Patients with malabsorption syndrome or difficulties in swallowing * The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy * Pregnant of breastfeeding women * The patient who participate in another clinical trial, or receives any drug for the trial * Uncontrolled peripheral neuropathy (more than grade 2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate MRI good response rate after the total neoadjuvant treatment | 16-20 weeks after SCRT | Good response rate is defined as the proportion of patients who reached mrTRG 1 or 2 and the absence of remote disease in the reevaluation period, with the denominator being the total number of patients who started total neoadjuvant treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival in 3 years | 3 years | defined as the time from the date of MRI of the pelvis of the reassessment period to relapse, death or last contact date. |
| Overall survival | 3 years | defined as the time from the date of the induction chemotherapy until the death or date of last contact |
| Describe the safety and tolerability of total neoadjuvant treatment. | 1 year | Incidence of adverse events (AEs), serious AEs, deaths and laboratory abnormalities in participants who received at least one dose of study treatment |
Countries
Brazil
Contacts
Primary ContactJuliana Souza
Backup ContactIsabele Small
Outcome results
None listed