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

Sun Yat-sen University

Status and phase

Unknown

Phase 2

Conditions

Rectal Cancer

Treatments

Radiation: Radiotherapy

Drug: mFOLFOX6

Study type

Interventional

Funder types

Other

Identifiers

NCT02887313

GIHSYSU11

Details and patient eligibility

About

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.