Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer
- Conditions
- Rectal Cancer
- Interventions
- Drug: FOLFOXIRI
- Registration Number
- NCT02217020
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Here, the investigators chose all the three active cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant regimen in treating patients with locally advanced rectal cancer.
- Detailed Description
Preoperative chemoradiotherapy could improve the local control of locally advanced rectal cancer, but the role was limited, only 5%. The adverse event cause by radiotherapy was severe. This single phase II trial was aimed to evaluate the efficacy of triplet regimen (FOLFOXIRI) in treating patients with locally advanced rectal cancer. All patients will receive the study regimen every 2 weeks for 4-6 cycles. MRI of the pelvic will be performed after 4 cycles of chemotherapy to assess clinical response. If the tumor response over 20% after 4 cycles of treatment, the patient will go to surgery (TME) directly or 2 more cycles of treatment before surgery under the decision of MDT. On the contrary, if the tumor show poor response (\<20%), radiotherapy will be performed before operation. After surgery, 6-8 cycles of mFOLFOX6 will be given as adjuvant chemotherapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FOLFOXIRI FOLFOXIRI patients received FOLFOXIRI alone for 4 cycles before surgery.
- Primary Outcome Measures
Name Time Method The ratio of tumor downstaging to stage 0 and stage I 2 year Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
- Secondary Outcome Measures
Name Time Method Average neoadjuvant rectal cancer score 2 year neoadjuvant rectal cancer score (NAR) =\[5\*pN-3\*(cT-pT)+12\]\^2/9.61 had been proposed and proven to be the surrogate endpoint of overall survival. It refered to the predictive value of lymphnode status and primary tumor downstaging on Overall survival of rectal cancer.
the local Recurrence rate 3 year the ratio of patients with local recurrence within 3 years
Recurrence free survival 3 years 3 years recurrence free survival of this group of patients
Reported Adverse events 2 years Number of patients with adverse events and severity according to NCI CTC 4.0 after treatment with this regimen.
Trial Locations
- Locations (1)
Gastrointestinal Hospital, Sun Yatsen University
🇨🇳Guangzhou, Guangdong, China