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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02887313

Collaborator

(none)

200

Enrollment

Location

Arm

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2016

Actual Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pathological complete response rate [2 years]
The pathologic outcome after neoadjuvant CRT showed no tumor residual.

Secondary Outcome Measures

Safety and compliance of treatment [2 years]
The adverse events after total neoadjuvant treatment
The ratio of tumor downstaging to stage 0 and stage I [2 years]
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Disease free survival [3 years]
3 years recurrence free survival of this group of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.