Short-course Radiotherapy With Induction and Consolidatio... | NCT04674696

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

NCT04674696

Sponsor

Instituto Nacional de Cancer, Brazil

Status

Unknown status

Last Update Posted

Dec 19, 2020Actual

Enrollment

54Estimated

Phase

Phase 2

Conditions

Rectal Cancer
Total Neoadjuvant Treatment

Interventions

Approach

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2020Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Dec 14, 2020

First Submission Date that Met QC Criteria

Dec 14, 2020

First Posted Date

Dec 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2020

Last Update Posted Date

Dec 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.	Other: Approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Approach	Other	Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	16-20 weeks after SCRT

Secondary Outcomes

Measure	Description	Time Frame
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.	3 years
Overall survival	defined as the time from the date of the induction chemotherapy until the death or date of last contact

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juliana Souza	Contact	5521988734435		juominelli@hotmail.com
Isabele Small	Contact	00552132076666		ismall@inca.gov.br

Overall Officials

Name	Affiliation	Role
Juliana Souza	Instituto Nacional de Cancer, Brazil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INCA- Instituto Nacional de Câncer	Recruiting	Rio de Janeiro		20231-050	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided