A Phase II Study of Neoadjuvant FOLFOXIRI Chemotherapy Alone in Treating Patients With Locally Advanced Rectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- FOLFOXIRI
- Conditions
- Rectal Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The ratio of tumor downstaging to stage 0 and stage I
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Yanhong Deng
Doctor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
FOLFOXIRI
patients received FOLFOXIRI alone for 4 cycles before surgery.
Intervention: FOLFOXIRI
Outcomes
Primary Outcomes
The ratio of tumor downstaging to stage 0 and stage I
Time Frame: 2 year
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Secondary Outcomes
- Average neoadjuvant rectal cancer score(2 year)
- the local Recurrence rate(3 year)
- Recurrence free survival(3 years)
- Reported Adverse events(2 years)