NCT05201430

Brief Summary

This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
14mo left

Started Aug 2021

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Aug 2021Jul 2027

Study Start

First participant enrolled

August 27, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

December 4, 2021

Last Update Submit

February 16, 2022

Conditions

Rectal Cancer

Keywords

Neoadjuvant chemotherapyLocally advanced rectal cancerFOLFOXIRICapeOX

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival

    Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first. Compare 3-year disease free survival in patients with locally advanced rectal cancer treated with either FOLFOXIRI or CapeOX neoadjuvant chemotherapy.

    3 years

Secondary Outcomes (8)

  • pathologic complete response rate

    1 year

  • major pathologic response rate

    1 year

  • objective response rate

    1 year

  • local recurrence rate

    3 years

  • overall survival

    5 years

  • +3 more secondary outcomes

Study Arms (2)

A: FOLFOXIRI

EXPERIMENTAL

Neoadjuvant chemotherapy with 3-4 cycles of FOLFOXIRI regimen, followed by surgery

Drug: FOLFOXIRI

B: CapeOX

EXPERIMENTAL

Neoadjuvant chemotherapy with 2-3 cycles of CapeOX regimen, followed by surgery

Drug: CapeOX

Interventions

FOLFOXIRIDRUG

irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1 oxaliplatin 85 mg/m² iv continue for 2 hours, D1 leucovorin 400 mg/m² iv continue for 2 hours, D1 5-FU 2400\~3200 mg/m² cont. inf. 48h, D1 repeat every 2 weeks (Q2W)

Also known as: 5-Fu, Oxaliplatin, Irinotecan, Surgery
A: FOLFOXIRI
CapeOXDRUG

oxaliplatin 130 mg/m2 iv continue for 2 hours, D1 capecitabine 1000mg/m2/d PO Bid, once every morning and evening D1-14 repeat every 3 weeks (Q3W)

Also known as: Capecitabine, Oxaliplatin, Surgery
B: CapeOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MRI evaluated of T3-4 or N+ rectal cancer;
  • Pathologically diagnosed of rectal adenocarcinoma;
  • to 75 years old;
  • Distance from lower margin of tumor to anus \<15 cm and suitable for anus-preserving resection;
  • Tumor amenable to radical resection;
  • Treatment-na?ve patients with no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer;
  • Laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 100×10\^9 /L, Hemoglobin ≥ 80 g/L, Serum bilirubin ≤ 24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60 U/L, Serum creatinine ≤ 110 umol/L;
  • Be capable to receive a surgery;
  • No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
  • No previous systemic chemotherapy for treating colorectal cancer;
  • Life expectancy of more than 3 months;
  • No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;
  • Be willing and able to understand the study and to provide written informed consent.

You may not qualify if:

  • End-stage cachexia patients;
  • Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate chemotherapy or surgery;
  • Metastatic carcinoma;
  • Incomplete or complete intestinal obstruction;
  • Known to be allergic to capecitabine, 5-Fu, oxaliplatin or irinotecan;
  • Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
  • Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric historysevere infection; active disseminated intravascular coagulation; active hepatitis, severe coagulation disorder patients;
  • History of other malignancy within the past 5 years except effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
  • Serious organic disease including but not limited to heart, kidney, brain, and lung.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Colorectal Surgery Fudan University Shanghai Caner Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

FOLFOXIRI protocolFluorouracilOxaliplatinIrinotecanSurgical Procedures, OperativeCapecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsDeoxycytidineCytidinePyrimidine NucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Ye Xu

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianan Guo

CONTACT

+86-021-6403538711307120071@fudan.edu.cn

Ye Xu

CONTACT

+86-021-64035387yexu@shmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief of Department of Colorectal Surgery

Study Record Dates

First Submitted

December 4, 2021

First Posted

January 21, 2022

Study Start

August 27, 2021

Primary Completion

June 1, 2024

Study Completion (Estimated)

July 1, 2027

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations

CN(1)