Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
NCT ID: NCT04674696
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2020-11-10
2022-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
Approach
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
Interventions
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Approach
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Instituto Nacional de Cancer, Brazil
OTHER_GOV
Responsible Party
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Principal Investigators
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Juliana Souza
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cancer, Brazil
Locations
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INCA- Instituto Nacional de Câncer
Rio de Janeiro, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Luana Cerva
Role: primary
Other Identifiers
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SHORT-ICAR
Identifier Type: -
Identifier Source: org_study_id