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

Primary Purpose

Rectal Cancer, Total Neoadjuvant Treatment

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Approach
Sponsored by
Instituto Nacional de Cancer, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • INCA- Instituto Nacional de CâncerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall survival
defined as the time from the date of the induction chemotherapy until the death or date of last contact
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

Full Information

First Posted
December 14, 2020
Last Updated
December 14, 2020
Sponsor
Instituto Nacional de Cancer, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT04674696
Brief Title
Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
Acronym
SHORT-ICAR
Official Title
Phase II Study of Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced High-risk Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Cancer, Brazil

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Total Neoadjuvant Treatment
Keywords
rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
Intervention Type
Other
Intervention Name(s)
Approach
Intervention Description
Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
Primary Outcome Measure Information:
Title
Evaluate MRI good response rate after the total neoadjuvant treatment
Description
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.
Time Frame
16-20 weeks after SCRT
Secondary Outcome Measure Information:
Title
Disease-free survival in 3 years
Description
defined as the time from the date of MRI of the pelvis of the reassessment period to relapse, death or last contact date.
Time Frame
3 years
Title
Overall survival
Description
defined as the time from the date of the induction chemotherapy until the death or date of last contact
Time Frame
3 years
Title
Describe the safety and tolerability of total neoadjuvant treatment.
Description
Incidence of adverse events (AEs), serious AEs, deaths and laboratory abnormalities in participants who received at least one dose of study treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Souza
Phone
5521988734435
Email
juominelli@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Isabele Small
Phone
00552132076666
Email
ismall@inca.gov.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Souza
Organizational Affiliation
Instituto Nacional de Cancer, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
INCA- Instituto Nacional de Câncer
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luana Cerva
Phone
00552132076666
Email
luana.cerva@inca.gov.br
First Name & Middle Initial & Last Name & Degree
Juliana O Souza, MD

12. IPD Sharing Statement

Learn more about this trial

Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer

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