Rectal CancerPhase 2SHORT-ICARNCT04674696
Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
A Phase 2 study testing Approach in people with Rectal Cancer and Total Neoadjuvant Treatment, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Total Neoadjuvant Treatment
- What is being tested?
- Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Nov 2020to Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
INCA- Instituto Nacional de Câncer
Rio de Janeiro, 20231-050
Luana Cerva, 00552132076666, luana.cerva@inca.gov.br
Juliana O Souza, MD
About this study
Official title: Phase II Study of Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced High-risk Rectal Cancer
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.
Read the 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.
- Conditions
- Rectal Cancer, Total Neoadjuvant Treatment
- Being tested
- Approach
- Keywords
- rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApproachOther
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles. Receives: Other: Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate MRI good response rate after the total neoadjuvant treatment
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.
Measured: 16-20 weeks after SCRT
Secondary outcomes (3)
Disease-free survival in 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.
Measured: 3 years
Overall survival
defined as the time from the date of the induction chemotherapy until the death or date of last contact
Measured: 3 years
Describe the safety and tolerability of total neoadjuvant treatment.
Incidence of adverse events (AEs), serious AEs, deaths and laboratory abnormalities in participants who received at least one dose of study treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start10 Nov 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Juliana Souza, Principal investigator, Instituto Nacional de Cancer, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674696
- Sponsor's protocol ID
- SHORT-ICAR
- Acronym
- SHORT-ICAR
- Status last verified
- Nov 2020
- First submitted
- 14 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced High-risk Rectal Cancer
- ClinicalTrials.gov ID
- NCT04674696
- Acronym / sponsor ID
- SHORT-ICAR / SHORT-ICAR
- Conditions
- Rectal Cancer, Total Neoadjuvant Treatment
- Keywords
- rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ApproachPatients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApproachPatients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles. | Other | Experimental |
Primary outcome
Evaluate MRI good response rate after the total neoadjuvant treatment
Time frame: 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.
3 secondary outcomes
Disease-free survival in 3 years
Time frame: 3 years
Overall survival
Time frame: 3 years
Describe the safety and tolerability of total neoadjuvant treatment.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana Souza principal investigator
Instituto Nacional de Cancer, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Approach in people with Rectal Cancer and Total Neoadjuvant Treatment, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Souza (5521988734435, juominelli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate MRI good response rate after the total neoadjuvant treatment (time frame: 16-20 weeks after SCRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.