Actively Recruiting
Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
Led by Sun Yat-sen University · Updated on 2019-01-23
776
Participants Needed
2
Research Sites
514 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term survival. Most importantly,chemoradiotherapy significantly increased surgical complication and poor long-term quality of life .In the absence of effective measures of predicting chemo-sensitivity, there is considerable risk of using any two-drug regimen for neoadjuvant therapy. Simultaneous use of the three chemotherapeutic drugs may be able to reduce the likelihood of resistance to both dual drug regimen and single drug regimen. The purpose of this study is to compare the efficacy and safety of three chemotherapeutic regimen known as FOLFOXIRI (the drug 5-fluorouracil, oxaliplatin, Irinotecan) with standard radiotherapy combined with capecitabine in neoadjuvant therapy for local advanced rectal cancer. The drugs in the FOLFOXIRI regimen are all FDA(Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
CONDITIONS
Official Title
Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Histological diagnosis of rectal adenocarcinoma
- For tumors 65 cm from the anal margin: cT3-4aN+M0 stage with no distant metastasis, lymph node positive or tumor breaking through muscular layer, no invasion of adjacent organs, positive MRF, and estimated R0 resection possible
- For tumors >5 cm from the anal margin: cT3c-4aN+M0 stage with no distant metastasis, lymph node positive or tumor breaking through muscular layer invading mesorectum more than 5 mm, no invasion of adjacent organs, positive MRF, and estimated R0 resection possible
- Preoperative staging by anal exam, high-resolution MRI and/or EUS; lymph node 610 mm or with typical metastasis characteristics; chest and abdomen CT, pelvic MRI to exclude distant metastasis
- Tumor lower edge confirmed within 12 cm from anal margin by MRI
- No signs of intestinal obstruction or obstruction relieved by proximal colostomy
- No prior rectal surgery, chemotherapy, radiation therapy, or biological treatment except endocrine therapy
- ECOG Performance Status 0-1
- Life expectancy over 2 years
- Laboratory values: white blood cell count >4000/mm3; platelet count >100000/mm3; hemoglobin >10 g/dL; liver function (SGOT and SGPT) <1.5 times upper limit of normal; bilirubin <1.5 mg/dL; creatinine <1.8 mg/dL
You will not qualify if you...
- Tumor invasion of surrounding organs (T4b) by preoperative staging
- Obturator lymph node metastasis
- Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease, recent myocardial infarction within 6 months, or congestive heart failure exceeding NYHA class II
- Poorly controlled severe hypertension
- History of HIV infection or active chronic hepatitis B or C with high viral DNA
- Other active serious infections
- Evidence of distant metastasis outside pelvis before surgery
- Cachexia and organ function decompensation
- History of pelvic or abdominal radiotherapy
- Multiple primary cancers
- Epilepsy requiring steroid or antiepileptic treatment
- History of other malignant tumors within 5 years except cured cervical carcinoma in situ or basal cell skin carcinoma
- Drug abuse or medical, psychological, or social conditions interfering with participation or evaluation
- Allergy to study drugs or related medications
- Any unstable condition endangering safety or compliance
- Pregnancy or lactation without adequate contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
Research Team
Z
ZhiZhong Pan
CONTACT
R
Rui-hua Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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