Back to resultsFOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study (FOTAC)
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mFOLFOX6
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal cancer, Neoadjuvant chemoradiation therapy
Eligibility 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.
Sites / Locations
- Gastrointestinal Hospital, Sun Yatsen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Locally advanced rectal cancer
Arm Description
Locally advanced rectal cancer receiveing total neoadjuvant treatment
Outcomes
Primary Outcome Measures
Pathological complete response rate
The pathologic outcome after neoadjuvant CRT showed no tumor residual.
Secondary Outcome Measures
Safety and compliance of treatment
The adverse events after total neoadjuvant treatment
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
Disease free survival
3 years recurrence free survival of this group of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02887313
Brief Title
FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study
Acronym
FOTAC
Official Title
Totally Neoadjuvant Chemoradiation Therapy With mFOLFOX6 in Locally Advanced Rectal Cancer: A Real World Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal cancer, Neoadjuvant chemoradiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Locally advanced rectal cancer
Arm Type
Experimental
Arm Description
Locally advanced rectal cancer receiveing total neoadjuvant treatment
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Other Intervention Name(s)
fluorouracil, oxaliplatin, Leucovorin
Intervention Description
Patients receive mFOLFOX6 for 4 cycles during neoadjuvant radiotherapy, and after CRT, another 4 cycles of mFOLFOX6 would be given before surgery.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Patietns received preoperative radiotherapy, 1.8-2.0GY/23-25F
Primary Outcome Measure Information:
Title
Pathological complete response rate
Description
The pathologic outcome after neoadjuvant CRT showed no tumor residual.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety and compliance of treatment
Description
The adverse events after total neoadjuvant treatment
Time Frame
2 years
Title
The ratio of tumor downstaging to stage 0 and stage I
Description
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Time Frame
2 years
Title
Disease free survival
Description
3 years recurrence free survival of this group of patients
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanhong Deng, PhD
Phone
086-020-38250745
Email
dengyanh@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal Hospital, Sun Yatsen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, PhD
Phone
0086-020-38250745
Email
dengyanh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, Phd
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study
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