NCT06812728

Brief Summary

A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
9mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Jan 2025Feb 2027

Study Start

First participant enrolled

January 25, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2027

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

February 1, 2025

Last Update Submit

February 15, 2025

Conditions

Rectum Cancer

Keywords

NeoadjuvantmFOLFIRINOXTNTWatch and wait approachComplete clinical responseSphincter sparing

Outcome Measures

Primary Outcomes (1)

  • Complete clinical response rate

    an absence of clinical, endoscopic or imaging evidence of a rectal tumor during the restaging of a patient with locally advanced rectal cancer after neoadjuvant therapy.

    6 months

Secondary Outcomes (4)

  • Toxicity of chemotherapy

    6 months

  • complete pathological response rectal cancer

    6 months

  • disease-free survival

    3 years

  • Overall survival

    5 years

Study Arms (2)

Arm A (mFolfox6)

ACTIVE COMPARATOR

Chemotherapy (mFolfox6) then radiochemotherapy

Drug: mFolfox6

Arm B (mFOLFIRINOX)

EXPERIMENTAL

Chemotherapy (mFOLFIRINOX) then radiochemotherapy

Drug: mFOLFIRINOX

Interventions

mFOLFIRINOXDRUG

Neoadjuvant chemotherapy

Arm B (mFOLFIRINOX)
mFolfox6DRUG

Neoadjuvant chemotherapy

Arm A (mFolfox6)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven rectal adenocarcinoma.
  • Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.
  • Resectable tumor, or considered as potentially resectable after CRT.
  • No distant metastases.
  • Patient eligible for surgery
  • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1.
  • No heart failure or coronary heart disease symptoms (even controlled).
  • No peripheral neuropathy \> grade 1.
  • No prior radiotherapy of the pelvis for any reason and no previous CT
  • No major comorbidity that may preclude the delivery of treatment
  • Adequate contraception in fertile patients.
  • Adequate hematologic function.
  • Adequate hepatic function.
  • \. Signed written informed consent.

You may not qualify if:

  • Metastatic disease
  • Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
  • Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
  • Medical history of angina pectoris or myocardial infarction
  • Other concomitant cancer.
  • Pregnant or breast-feeding woman.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Yostena Mekhail, MD,PhD

    Menoufia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

E Morkos

CONTACT

00201061323285yoyonagy7@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

February 1, 2025

First Posted

February 6, 2025

Study Start

January 25, 2025

Primary Completion (Estimated)

January 25, 2027

Study Completion (Estimated)

February 25, 2027

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

EG(1)