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Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

FOLFOXIRI

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Local Advanced Rectal Cancer, Total Neoadjuvant Therapy, FOLFOXIRI

Eligibility Criteria

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

Inclusion Criteria:

Age ≥ 18 to 75 years at diagnosis
Diagnosis of rectal adenocarcinoma
ECOG status: 0～1
Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)
Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
Leukocytes ≥ 4.0 x109/ L,
Absolute neutrophil count (ANC) ≥ 2.0 x109/ L
Platelet count ≥ 100 x109/ L,
Hemoglobin (Hb) ≥ 9g/ dL.
Total bilirubin ≤1.5 x the upper limit of normal (ULN).
Alanine aminotransferase (ALT) ≤ 3 x ULN
Aspartate aminotransferase (AST) ≤ 3 x ULN.
Serum creatinine ≤ 1.5 x the ULN.
Signed informed consent;

Exclusion Criteria:

Patient had received pelvic radiotherapy
Patient had received systemic chemotherapy
Pregnant and Nursing women
Had metastatic disease
Uncontrolled co-morbid illnesses or other concurrent disease
Patient had second malignant disease within 5 years
Patients refused to signed informed consent.

Sites / Locations

Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFOXIRI

Arm Description

irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle

Outcomes

Primary Outcome Measures

Pelvic complete resection rate

Pathologic confirmation

Secondary Outcome Measures

The rate of local control

Imaging diagnosis

Disease free survival (DFS)

Imaging diagnosis

Overall survival

Record document

The rate of receive chemoradiation

Record document

The rate of clinical complete response after 4 cycles of FOLFOXIRI

Imaging diagnosis

The rate of pathological complete response after 4 cycles of FOLFOXIRI

Pathologic confirmation

The incidence of >=3 grade adverse events

Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Full Information

NCT ID

NCT02942563

First Posted

October 21, 2016

Last Updated

January 1, 2018

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02942563

Brief Title

Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Official Title

A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2016 (Actual)

Primary Completion Date

September 30, 2019 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

5. Study Description

Brief Summary

The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological complete response (pCR), which was associated with overall survival (OS). Here, the investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation and to improve the ratio of pCR further.

Detailed Description

This is a multicenter, phase II trial to assess the efficacy/safety of triplet regimen (FOLFOXIRI) for patients with LARC. After 4 cycles of FOLFOXIRI and 2 weeks later, the patients will be evaluated by senior radiologist, oncologist and surgeon through pelvic MRI, CT and Positron Emission Computed Tomography (PET-CT). The patients will go to surgery (TME) if the tumor response is good enough to have complete resection under the decision of MDT,otherwise, the patients will receive pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/M^2, bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.

6. Conditions and Keywords

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

Rectal Cancer

Keywords

Local Advanced Rectal Cancer, Total Neoadjuvant Therapy, FOLFOXIRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FOLFOXIRI

Arm Type

Experimental

Arm Description

irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle

Intervention Type

Drug

Intervention Name(s)

FOLFOXIRI

Other Intervention Name(s)

Irinotecan, Oxaliplatin, 5-FU, Capecitabine

Intervention Description

Irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle for 4-6 cycles, Chemoradiation for patients who are not suitable to surgery: Pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/m², bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.

Primary Outcome Measure Information:

Title

Pelvic complete resection rate

Description

Pathologic confirmation

Time Frame

Up to 10 weeks

Secondary Outcome Measure Information:

Title

The rate of local control

Description

Imaging diagnosis

Time Frame

3 years

Title

Disease free survival (DFS)

Description

Imaging diagnosis

Time Frame

3 years

Title

Overall survival

Description

Record document

Time Frame

3 years

Title

The rate of receive chemoradiation

Description

Record document

Time Frame

Up to 10 weeks

Title

The rate of clinical complete response after 4 cycles of FOLFOXIRI

Description

Imaging diagnosis

Time Frame

Up to 10 weeks

Title

The rate of pathological complete response after 4 cycles of FOLFOXIRI

Description

Pathologic confirmation

Time Frame

Up to 10 weeks

Title

The incidence of >=3 grade adverse events

Description

Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Time Frame

2 years

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: Age ≥ 18 to 75 years at diagnosis Diagnosis of rectal adenocarcinoma ECOG status: 0～1 Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2) Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Leukocytes ≥ 4.0 x109/ L, Absolute neutrophil count (ANC) ≥ 2.0 x109/ L Platelet count ≥ 100 x109/ L, Hemoglobin (Hb) ≥ 9g/ dL. Total bilirubin ≤1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT) ≤ 3 x ULN Aspartate aminotransferase (AST) ≤ 3 x ULN. Serum creatinine ≤ 1.5 x the ULN. Signed informed consent; Exclusion Criteria: Patient had received pelvic radiotherapy Patient had received systemic chemotherapy Pregnant and Nursing women Had metastatic disease Uncontrolled co-morbid illnesses or other concurrent disease Patient had second malignant disease within 5 years Patients refused to signed informed consent.

Central Contact Person:

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

Ming Ye, Master

Phone

+862168383459

renjiyeming@163.com

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

Qi Lu, Master

Phone

+862158752345

Ext

33364

luqi@renji.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Ye, Master

Organizational Affiliation

Locations: China, Shanghai Shanghai Jiaotong University School of Medicine, Renji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Ye, Master

Phone

+862168383459

renjiyeming@163.com

First Name & Middle Initial & Last Name & Degree

Qi Lu, Master

Phone

+862158752345

Ext

33364

luqi@renji.com

12. IPD Sharing Statement

Learn more about this trial

Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

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