Clinical trial NCT04674696: Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
Official title: Phase II Study of Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced High-risk Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Total Neoadjuvant Treatment
Keywords: rectal cancer
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2020-12-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment.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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluate MRI good response rate after the total neoadjuvant treatment
timeFrame: 16-20 weeks after SCRT
Secondary outcomes:
measure: Disease-free survival in 3 years
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Describe the safety and tolerability of total neoadjuvant treatment.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: INCA- Instituto Nacional de Câncer
Study officials:
affiliation: Instituto Nacional de Cancer, Brazil
name: Juliana Souza
role: PRINCIPAL_INVESTIGATOR
References: