NCT05081687

Brief Summary

Standard therapy for localized rectal cancer includes chemotherapy and radiation therapy, followed by a "recovery" period of 7-12 weeks, surgery and adjuvant chemotherapy for 3-6 months. Even though this protocol achieves high cure rates, many patients need a rectal amputation with placement of definitive colostomies. About 10-20% of patients have a complete clinical response to chemo-radiation and no tumor can be found in the surgical specimen. These patients can be followed with close surveillance and avid surgery. The aim of this study is to evaluate if a strategy including the use of a highly active chemotherapy called "FOLFIRINOX" during the 12 weeks between the end of radiation therapy and evaluation for surgery increases the rates of complete response and, therefore, allows more patients to undergo non-surgical management.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2022

Enrollment Period

3.8 years

First QC Date

October 5, 2021

Last Update Submit

October 10, 2023

Conditions

Colorectal Neoplasms

Keywords

Rectal cancerNeoadjuvant chemo-radiationTotal neoadjuvant therapyWatch-and-wait

Outcome Measures

Primary Outcomes (1)

  • cCR + PathCR

    Complete clinical response or pathological response

    12 weeks after the end of chemoradiation

Secondary Outcomes (3)

  • Rate of R0 resection

    12 weeks

  • Rate of organ preservation

    6 months after surgery

  • Overall toxicity

    12 weeks

Study Arms (2)

Total neoadjuvant therapy (TNT)

EXPERIMENTAL

4 cycles of mFOLFIRINOX every 14 days: * Oxaliplatin 85 mg/m2 * Irinotecan 150mg/m2 * 5-FU 2.400mg/m2 * Dexamethasone 12mg * Atropine 0.5mg * Netupitant/palonosetron

Drug: Folfirinox

Standard of care

NO INTERVENTION

Standard post-radiation care

Interventions

FolfirinoxDRUG

5-FU 2400mg/m2; Oxaliplatin 85 mg/m2, Irinotecan 150mg/m2

Also known as: mFOLFIRINOX, FOLFOXIRI, 5-FU, oxaliplatin, irinotecan
Total neoadjuvant therapy (TNT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 y/o
  • Biopsy-confirmed rectal adenocarcinoma
  • Tumor Stage T3+ or N+ M0
  • Adequate liver function (total bilirubin \< = 4.0)
  • Adequate kidney function (calculate creatinine-clearance \>=30ml/m2/min)
  • Adequate bone marrow function (Platelet counts \>=90.000, hemoglobin \>=8mg/dl, neutrophile count \>= 1.500/cm3)
  • Completed chemo-radiation with at least 54Gy and capecitabine 1650mg/m2/d

You may not qualify if:

  • Prior tumor resection
  • Prior radiation to the pelvis
  • Prior chemotherapy for rectal cancer
  • Life expectancy \< 6 months
  • Unfit for surgery
  • Need for urgent/ immediate surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Municipal Vila Santa Catarina

São Paulo, 04378-500, Brazil

RECRUITING

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Interventions

folfirinoxFOLFOXIRI protocolFluorouracilOxaliplatinIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesOrganic ChemicalsCamptothecinAlkaloids

Study Officials

  • Diogo Gomes, MD

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diogo Gomes, MD

CONTACT

+55-11-2151-8056diogo.gomes@einstein.br

Leticia Brito, MD

CONTACT

+55-11-2151-8056leticia.brito@einstein.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized 1:1 to one of two arms: TNT and conventional therapy (control). Randomization will be stratified by study site and tumor stage (II vs III)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 18, 2021

Study Start

February 20, 2020

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

October 11, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)