FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study

NCT02887313 | Unknown Phase 2

• 1 other identifier: GIHSYSU11
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative 5FU based chemoradiotherapy is still the standard of treatment for locally advanced rectal cancer. About 15-20% of patients would achieve pathologic complete response (pCR) after neoadjuvant CRT, and the survival outcome was much better than that of non-pCR. Total neoadjuvant treatment had been evaluated a lot in recent years, including induction chemotherapy or consolidation chemotherapy, or concurrent chemoradiotherapy. We aimed to evaluated the safety and efficacy of total neoadjuvant treatemnt in locally advanced rectal cancer.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Neoadjuvant chemoradiation therapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  The pathologic outcome after neoadjuvant CRT showed no tumor residual.

  2 years

Secondary Outcomes (3)

• Safety and compliance of treatment

  2 years

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

  2 years

• Disease free survival

  3 years

Study Arms (1)

Locally advanced rectal cancer

EXPERIMENTAL

Locally advanced rectal cancer receiveing total neoadjuvant treatment

Drug: mFOLFOX6; Radiation: Radiotherapy

Interventions

mFOLFOX6 DRUG

Patients receive mFOLFOX6 for 4 cycles during neoadjuvant radiotherapy, and after CRT, another 4 cycles of mFOLFOX6 would be given before surgery.

Also known as: fluorouracil, oxaliplatin, Leucovorin

Locally advanced rectal cancer

Radiotherapy RADIATION

Patietns received preoperative radiotherapy, 1.8-2.0GY/23-25F

Locally advanced rectal cancer

Eligibility Criteria

• Age: 18 Years - 75 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

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Fluorouracil; Oxaliplatin; Leucovorin; Radiotherapy

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; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Therapeutics

Study Officials

• Yanhong Deng, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanhong Deng, PhD

CONTACT

086-020-38250745; dengyanh@mail.sysu.edu.cn

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: Professor

Study Record Dates

• First Submitted: August 27, 2016
• First Posted: September 2, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)