FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for Circumferential Radial Margin (CRM) Positive Rectal Cancer

NCT03161574 | Withdrawn Phase 2 DMC

• 1 other identifier: FOLOXIRIREC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant 5-Fu based chemoradiation followed by surgery is a standard treatment for locally advanced rectal cancer. However, radiation-related side effects could not be neglected. But this multimodality strategy failed to improve survival. Neoadjuvant chemotherapy alone may be an alternative strategy to minimize treatment-related toxicities without compromising the oncology outcome. Thus, patients with MRI-defined CRM-positive rectal cancer will receive 6 cycles of neoadjuvant treatment with FOLFOXIRI followed by surgery. The purpose of the study is to evaluate the efficacy of FOLFOXIRI alone as neoadjuvant treatment in treating patients with locally advanced rectal cancer.

Conditions

Rectal Cancer

Keywords

neochemotherapy; CRM

Outcome Measures

Primary Outcomes (2)

• The rate of negative circumferential margin status

  Evaluation of the circumferential margin status (positive or negative) in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)

  30 days

• The rate of R0 resection

  Evaluation of the resection margin status (positive or negative) in the rectal specimen

  30 days

Secondary Outcomes (4)

• The rate of tumor downstaging to stage 0 and stage Ⅰ

  2 years

• the local recurrence rate

  3 year

• Recurrence free survival

  3 year

• Reported Adverse events

  3 years

Study Arms (1)

FOLFOXIRI

EXPERIMENTAL

patients with CRM positive who received FOLFOXIRI alone for 6 cycles before surgery

Drug: FOLFOXIRI

Interventions

FOLFOXIRI DRUG

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

Also known as: 5-Fluorouracil, Oxaliplatin, Irinotecan

FOLFOXIRI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adenocarcinoma of the rectum
• Age: 18-70years old
• Signed informed consent; able to comply with study and/or followup procedures
• Stage of the primary tumor may be determined by MRI as CRM positive
• Tumor amenable to curative resection
• Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
• Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 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) and aspartate aminotransferase (AST) ≤ 5 x ULN.
• Alkaline phosphatase limit ≤ 5x ULN.
• Amylase and lipase ≤ 1.5 x the ULN.
• Serum creatinine ≤ 1.5 x the ULN.
• No renal disease that would preclude study treatment or followup
• ECOG status: 0～1

You may not qualify if:

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
• Less than 4 weeks since prior participation in any investigational drug study
• History of invasive rectal malignancy, regardless of disease free interval
• Uncontrolled hypertension
• Cardiovascular disease that would preclude study treatment or followup
• Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
• Synchronous colon cancer
• Pregnant or nursing
• Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
• No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
• patients refused to signed informed consent.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi Autonomous Region, 530021, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

FOLFOXIRI protocol; Fluorouracil; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Yuzhou Qin

  Affiated Tumor Hospital of Guangxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: August 11, 2017
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2022
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)