- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02887313
FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study (FOTAC)
April 30, 2020 updated by: Yanhong Deng, Sun Yat-sen University
Totally Neoadjuvant Chemoradiation Therapy With mFOLFOX6 in Locally Advanced Rectal Cancer: A Real World Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yanhong Deng, PhD
- Phone Number: 086-020-38250745
- Email: dengyanh@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510655
- Recruiting
- Gastrointestinal Hospital, Sun Yatsen University
-
Contact:
- Yanhong Deng, PhD
- Phone Number: 0086-020-38250745
- Email: dengyanh@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Locally advanced rectal cancer
Locally advanced rectal cancer receiveing total neoadjuvant treatment
|
Patients receive mFOLFOX6 for 4 cycles during neoadjuvant radiotherapy, and after CRT, another 4 cycles of mFOLFOX6 would be given before surgery.
Other Names:
Patietns received preoperative radiotherapy, 1.8-2.0GY/23-25F
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological complete response rate
Time Frame: 2 years
|
The pathologic outcome after neoadjuvant CRT showed no tumor residual.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Safety and compliance of treatment
Time Frame: 2 years
|
The adverse events after total neoadjuvant treatment
|
2 years
|
Disease free survival
Time Frame: 3 years
|
3 years recurrence free survival of this group of patients
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yanhong Deng, PhD, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
May 1, 2019
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
August 27, 2016
First Submitted That Met QC Criteria
August 29, 2016
First Posted (Estimate)
September 2, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2020
Last Update Submitted That Met QC Criteria
April 30, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- GIHSYSU11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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