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

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ClinicalTrials.gov Identifier: NCT02887313
Recruitment Status : Recruiting
First Posted : September 2, 2016
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: mFOLFOX6 Radiation: Radiotherapy Phase 2

Detailed Description:
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. However, distant metastasis would occur in about 30% of patients even after CRT. To improve the survival of rectal cancer patients, we hope to improve the pCR rate. In our previous FOWARC study, mFOLFOX6 with radiation had the pCR rate of 27.5%. It had been reported that adding FOLFOX after neoadjuvant chemo radiation in locally advanced rectal cancer would improve pCR rate. Nowadays, induction or consolidation chemotherapy or concurrent chemoradiotherapy had been used in clincal practice. Here, we are going to evaluate the safety and efficacy of total neoadjuvant therapy in real world.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Totally Neoadjuvant Chemoradiation Therapy With mFOLFOX6 in Locally Advanced Rectal Cancer: A Real World Study
Study Start Date : July 2016
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Locally advanced rectal cancer
Locally advanced rectal cancer receiveing total neoadjuvant treatment
Drug: mFOLFOX6
Patients receive mFOLFOX6 for 4 cycles during neoadjuvant radiotherapy, and after CRT, another 4 cycles of mFOLFOX6 would be given before surgery.
Other Names:
  • fluorouracil
  • oxaliplatin
  • Leucovorin

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




Primary Outcome Measures :
  1. Pathological complete response rate [ Time Frame: 2 years ]
    The pathologic outcome after neoadjuvant CRT showed no tumor residual.


Secondary Outcome Measures :
  1. Safety and compliance of treatment [ Time Frame: 2 years ]
    The adverse events after total neoadjuvant treatment

  2. The ratio of tumor downstaging to stage 0 and stage I [ Time Frame: 2 years ]
    Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I

  3. Disease free survival [ Time Frame: 3 years ]
    3 years recurrence free survival of this group of patients



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
  • No renal disease that would preclude study treatment or follow-up
  • ECOG status: 0~1

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887313


Contacts
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Contact: Yanhong Deng, PhD 086-020-38250745 dengyanh@mail.sysu.edu.cn

Locations
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China, Guangdong
Gastrointestinal Hospital, Sun Yatsen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yanhong Deng, PhD    0086-020-38250745    dengyanh@mail.sysu.edu.cn   
Principal Investigator: Yanhong Deng, Phd         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yanhong Deng, PhD Sun Yat-sen University
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Responsible Party: Yanhong Deng, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02887313    
Other Study ID Numbers: GIHSYSU11
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Yanhong Deng, Sun Yat-sen University:
Rectal cancer
Neoadjuvant chemoradiation therapy
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Fluorouracil
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances