Status:
UNKNOWN
Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3 rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need radiation for loc...
Detailed Description
OBJECTIVES: Primary Compare the objective response rate and the rate of local-regional relapse in patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based chemoradiotherapy or ...
Eligibility Criteria
Inclusion
- Diagnosis of adenocarcinoma of the rectum
- Age: 18-75 years old
- Stage of the primary tumor may be determined by ultrasound or MRI
- Stage II (T\_3-4, N\_0 \[N\_0 is defined as all imaged lymph nodes \< 1.0 cm\]) OR stage III (T\_1-4, N\_1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\]
- 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
- 15 days prior recruit, meet the following criteria: Hematopoietic
- Absolute neutrophil count ≥ 1,200/mm\^3
- Platelet count ≥ 100,000/mm\^3 Hepatic
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- AST ≤ 2 times ULN\*
- No hepatic disease that would preclude study treatment or follow-up
- No uncontrolled coagulopathy Renal
- Creatinine clearance \> 50 mL/min
- No renal disease that would preclude study treatment or follow-up
- ECOG status: 0～1
Exclusion
- Hypersensitivity to fluorouracil, or oxaliplatin
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT01211210
Start Date
June 1 2010
End Date
June 1 2020
Last Update
May 22 2015
Active Locations (1)
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1
Gastrointestinal Hospital, Sun Yatsen University
Guangzhou, Guangdong, China, 510655