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Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer (SHORT-ICAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674696
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Total Neoadjuvant Treatment Other: Approach Phase 2

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 Patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment.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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced High-risk Rectal Cancer
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
 Other: Approach
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Disease-free survival in 3 years [ Time Frame: 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.

  2. Overall survival [ Time Frame: 3 years ]
    defined as the time from the date of the induction chemotherapy until the death or date of last contact

  3. Describe the safety and tolerability of total neoadjuvant treatment. [ Time Frame: 1 year ]
    Incidence of adverse events (AEs), serious AEs, deaths and laboratory abnormalities in participants who received at least one dose of study treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674696


Contacts
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Contact: Juliana Souza 5521988734435 juominelli@hotmail.com
Contact: Isabele Small 00552132076666 ismall@inca.gov.br

Locations
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Brazil
INCA- Instituto Nacional de Câncer Recruiting
Rio de Janeiro, Brazil, 20231-050
Contact: Luana Cerva    00552132076666    luana.cerva@inca.gov.br   
Principal Investigator: Juliana O Souza, MD         
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
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Principal Investigator: Juliana Souza Instituto Nacional de Cancer, Brazil
More Information
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Responsible Party: Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT04674696    
Other Study ID Numbers: SHORT-ICAR
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Instituto Nacional de Cancer, Brazil:
rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases