Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer

NCT03484221 | Unknown Phase 2

• 1 other identifier: LGIOG-2017-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and XELOX chemotherapy in the patients with locally advanced rectal cancer.

Conditions

Rectal Neoplasms; Drug Therapy; Radiation

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 years

Secondary Outcomes (7)

• Tumor regression grade (TRG)

  2 years

• Disease free survival

  3 years

• Overall survival time

  3 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  3 years

• ctDNA change

  3 years

Study Arms (1)

FOLFOXIRI+short-course radiation+XELOX

EXPERIMENTAL

Firstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy\*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by surgery.

Drug: FOLFOXIRI; Radiation: Short-Course Radiation Therapy(5Gy*5); Drug: XELOX

Interventions

FOLFOXIRI DRUG

IRINOTECAN 150 mg/m\^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m\^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m\^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m\^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months).

Also known as: Irinotecan, Oxaliplatin, 5-Fluorouracil

FOLFOXIRI+short-course radiation+XELOX

Short-Course Radiation Therapy(5Gy*5) RADIATION

Patients received a short-course radiation therapy(5Gy\*5) after 4 cycles of FOLFOXIRI.

FOLFOXIRI+short-course radiation+XELOX

XELOX DRUG

OXALIPLATIN 130 mg/m\^2 IV over 2-h, day 1 Capecitabine 1000 mg/m\^2 twice daily days 1-14 every 3 weeks for 4 cycles.

Also known as: Capecitabine, Oxaliplatin

FOLFOXIRI+short-course radiation+XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old
• Primary and pathological diagnosis of rectal adenocarcinoma
• Radiographic evaluation of initial resectable rectal cancer
• T staging was determined by MRI as T3N+ or T4Nx
• Distal border of the tumor must be located \< 12 cm from the anal verge
• ECOG status: 0～1
• Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
• Neutrophil count≥1.5×10\^9/L Platelet count≥90×10\^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 \* ULN Alanine aminotransferase (ALT)≤2.5 \* ULN Aspartate aminotransferase (AST)≤2.5 \* ULN Alkaline phosphatase (ALP)≤2.5 \* ULN
• \- Signed informed consent; able to comply with study and/or follow- up procedures

You may not qualify if:

• Previous treatment with oxaliplatin, irinotecan or fluorouracil
• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
• Clear indication of involvement of the pelvic side walls by imaging
• With distant metastasis
• A history of malignant rectal cancer (i. e. sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer
• Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months
• Digestive system diseases that would preclude study treatment or follow-up within the past 6 months
• Gastric ulcers or duodenal ulcers for the treatment of resistance;
• or 4 grade gastrointestinal bleeding / bleeding;
• Gastrointestinal perforation / fistula;
• Abdominal abscess;
• Infectious or inflammatory bowel disease
• HIV infection and/or active hepatitis B virus infection
• Pregnant or lactating women. Fertile patients must use effective contraception
• Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

China Medical University

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

FOLFOXIRI protocol; Irinotecan; Oxaliplatin; Fluorouracil; XELOX; Capecitabine

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)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jingdong Zhang

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanhe Wang, PhD

CONTACT

18900918794; zhangjd0228@hotmail.com

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: Director

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2022
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

CN (1)