Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer

NCT02217020 | Completed Phase 2

• 1 other identifier: GIHSYSU07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Here, the investigators chose all the three active cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant regimen in treating patients with locally advanced rectal cancer.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Locally advanced rectal cancer; Neoadjuvant; chemotherapy; FOLFOXIRI

Outcome Measures

Primary Outcomes (1)

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

  Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I

  2 year

Secondary Outcomes (4)

• Average neoadjuvant rectal cancer score

  2 year

• the local Recurrence rate

  3 year

• Recurrence free survival

  3 years

• Reported Adverse events

  2 years

Study Arms (1)

FOLFOXIRI

EXPERIMENTAL

patients received FOLFOXIRI alone for 4 cycles before surgery.

Drug: FOLFOXIRI

Interventions

FOLFOXIRI DRUG

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

Also known as: 5-FU, 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: 18-70 years old
• Signed informed consent; able to comply with study and/or follow- up procedures
• Stage of the primary tumor may be determined by ultrasound or MRI
• Stage II (T3-4, N0 \[N0 is defined as all imaged lymph nodes \< 1.0 cm\]) OR stage III (T1-4, N1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\]
• Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
• Distal border of the tumor must be located \< 12 cm from the anal verge
• 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.

You may not qualify if:

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
• No More than 4 weeks since prior participation in any investigational drug study
• More than 4 weeks since prior participation in any investigational drug study
• Clear indication of involvement of the pelvic side walls by imaging
• With distant metastasis
• History of invasive rectal malignancy, regardless of disease-free interval
• Fertile patients must use effective contraception
• Uncontrolled hypertension
• Cardiovascular disease that would preclude study treatment or follow-up
• Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
• Synchronous colon cancer
• Pregnant or nursing, Fertile patients do not use effective contraception
• 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

• Sun Yat-sen University: lead

Study Sites (1)

Gastrointestinal Hospital, Sun Yatsen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (1)

• Zhang J, Li J, Huang M, Xie X, Cai Y, Hu H, Ling J, Wu Z, Deng Y. Neoadjuvant Modified FOLFOXIRI With Selective Radiotherapy in Locally Advanced Rectal Cancer: Long-term Outcomes of Phase II Study and Propensity-Score-Matched Comparison With Chemoradiotherapy. Dis Colon Rectum. 2023 Jul 1;66(7):934-945. doi: 10.1097/DCR.0000000000002424. Epub 2022 Jul 12.

  PMID: 35834598 DERIVED

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 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: Doctor

Study Record Dates

• First Submitted: August 10, 2014
• First Posted: August 15, 2014
• Study Start: August 15, 2014
• Primary Completion: September 15, 2016
• Study Completion: August 15, 2017
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

CN (1)