Status:
UNKNOWN
Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Rectal Cancer
Total Neoadjuvant Treatment
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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. Pati...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04674696
Start Date
November 10 2020
End Date
June 1 2022
Last Update
December 19 2020
Active Locations (1)
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1
INCA- Instituto Nacional de Câncer
Rio de Janeiro, Brazil, 20231-050