- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03170115
Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer (ICAR)
Phase II Randomized Study of Induction Chemotherapy Followed by Chemoradiotherapy With or Without Aspirin in High Risk Locally Advanced Rectal Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
Methods: This is a randomized trial to evaluate induction treatment with XELOX and Capecitabine-based chemoradiotherapy with or without aspirin in a high-risk population selected by MRI. High-risk will be defined by presence of at least one of the following criteria on high-resolution thin-slice MRI (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. Random assignment of treatment will be stratified by MRI tumour regression grade. All the patients enrolled in the study will receive XELOX every 21 days for four cycles, unless unacceptable toxicity or progression is detected. After this treatment, patients will be randomized to receive Capecitabine-based chemoradiotherapy with aspirin or placebo (Capecitabine 850 mg/m² 5 days per week combined with radiotherapy with total dose of 50.4 Gy in 28 days). After 8-10 weeks, they 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 Patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment.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, 11 patients must be included in each group during the first stage and 20 during the second stage. A treatment regimen will be considered effective if more than 18 patients of the total 31 show downstaging (final analysis), reaching 80% power with an alpha of 0.05 level of significance.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Rio de Janeiro, Brazil, 20231-050
- INCA- Instituto Nacional de Câncer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
- Active gastrointestinal bleeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aspirin
Induction chemotherapy followed by chemoradiotherapy with aspirin Aspirin 100mg daily during the chemoradiotherapy
|
chemoradiotherapy with capecitabine and aspirin Aspirin daily during chemoradiotherapy
Other Names:
|
Placebo Comparator: Placebo Oral Tablet
Induction chemotherapy followed by chemoradiotherapy without aspirin Placebo daily during the chemoradiotherapy
|
chemoradiotherapy with capecitabine and placebo Placebo daily during chemoradiotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor downstaging after induction chemotherapy followed by chemoradiotherapy with or without aspirin
Time Frame: 8-10 weeks after chemoradiotherapy
|
This will be assessed by MR imaging 8-10 weeks after chemoradiotherapy and it will be considered tumor downstaging if mrTRG 1 to 3
|
8-10 weeks after chemoradiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological Tumor response rate after induction chemotherapy
Time Frame: 3-4 weeks after last induction chemotherapy
|
This will be assessed by MR imaging after induction chemotherapy
|
3-4 weeks after last induction chemotherapy
|
Pathological Tumor response rate
Time Frame: 10-12 weeks after chemoradiotherapy
|
Amount of tumor regression after surgery according to the guideline including Mandard
|
10-12 weeks after chemoradiotherapy
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Pathologic complete response
Time Frame: 8-10 weeks after chemoradiotherapy
|
it will be defined as the absence of residual invasive cancer on pathological evaluation of the complete resected rectal specimen
|
8-10 weeks after chemoradiotherapy
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Disease-free survival
Time Frame: 3 years
|
defined as the time from surgery to relapse or death, whichever occurred first
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3 years
|
Overall survival
Time Frame: 5 years
|
defined as the time from surgery to death, whichever occurred first
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5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luiz Henrique Araujo, MD, PHD, National Cancer Institute, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- ICAR trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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