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Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer (RCNAC)

Primary Purpose

Rectal Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

FOLFOXIRI

CapeOX

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Neoadjuvant chemotherapy, Locally advanced rectal cancer, FOLFOXIRI, CapeOX

Eligibility Criteria

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

Inclusion Criteria:

MRI evaluated of T3-4 or N+ rectal cancer;
Pathologically diagnosed of rectal adenocarcinoma;
18 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.

Exclusion Criteria:

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.

Sites / Locations

Department of Colorectal Surgery Fudan University Shanghai Caner CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A: FOLFOXIRI

B: CapeOX

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

pathologic complete response rate

Defined as the ratio of patients with pathologic TRG 0

major pathologic response rate

Defined as the ratio of patients with pathologic TRG 0 or 1

objective response rate

Defined as the ratio of patients with MRI-TRG 1, 2 or 3

local recurrence rate

Defined as the ratio of patients with local recurrence within 3 years.

overall survival

Defined as the length of time from randomization date until the date of death from any cause.

quality of life as assessed by EORTC QOL-C30

Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-C30 version 3

quality of life as assessed by EORTC QOL-CR29

Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-CR29.

adverse event

Number of patients with adverse events and severity according to NCI CTC 5.0 after neoadjuvant chemotherapy.

Full Information

NCT ID

NCT05201430

First Posted

December 4, 2021

Last Updated

February 16, 2022

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05201430

Brief Title

Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

Acronym

RCNAC

Official Title

Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 27, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

Neoadjuvant chemotherapy, Locally advanced rectal cancer, FOLFOXIRI, CapeOX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A: FOLFOXIRI

Arm Type

Experimental

Arm Description

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

Arm Title

B: CapeOX

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

FOLFOXIRI

Other Intervention Name(s)

5-Fu, Oxaliplatin, Irinotecan, Surgery

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

CapeOX

Other Intervention Name(s)

Capecitabine, Oxaliplatin, Surgery

Intervention Description

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)

Primary Outcome Measure Information:

Title

3-year disease free survival

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

pathologic complete response rate

Description

Defined as the ratio of patients with pathologic TRG 0

Time Frame

1 year

Title

major pathologic response rate

Description

Defined as the ratio of patients with pathologic TRG 0 or 1

Time Frame

1 year

Title

objective response rate

Description

Defined as the ratio of patients with MRI-TRG 1, 2 or 3

Time Frame

1 year

Title

local recurrence rate

Description

Defined as the ratio of patients with local recurrence within 3 years.

Time Frame

3 years

Title

overall survival

Description

Defined as the length of time from randomization date until the date of death from any cause.

Time Frame

5 years

Title

quality of life as assessed by EORTC QOL-C30

Description

Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-C30 version 3

Time Frame

3 years

Title

quality of life as assessed by EORTC QOL-CR29

Description

Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-CR29.

Time Frame

3 years

Title

adverse event

Description

Number of patients with adverse events and severity according to NCI CTC 5.0 after neoadjuvant chemotherapy.

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

Eligibility Criteria

Inclusion Criteria: MRI evaluated of T3-4 or N+ rectal cancer; Pathologically diagnosed of rectal adenocarcinoma; 18 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tianan Guo

Phone

+86-021-64035387

11307120071@fudan.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Ye Xu

Phone

+86-021-64035387

yexu@shmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Xu

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Colorectal Surgery Fudan University Shanghai Caner Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ye Xu

Phone

+86-21-64175590

yexu@shmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Proper legal IPD will be shared when publishing articles.

Learn more about this trial

Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

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