RecruitingPhase 3NCT03671252

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


Sponsor

Sun Yat-sen University

Enrollment

776 participants

Start Date

Nov 16, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatment approaches for locally advanced rectal cancer close to or at the anus: a standard approach using long-course radiation with an oral chemotherapy pill (capecitabine) versus a newer approach using three chemotherapy drugs together (FOLFOXIRI) without radiation, to find out which works better before surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with rectal cancer (adenocarcinoma) confirmed by biopsy - Your tumor is in the lower rectum (close to the anal margin) and has grown through the bowel wall and/or involves lymph nodes, or is in a higher location but is still locally advanced - Your cancer has not spread to distant organs (no distant metastases) - You are considered able to have surgery to remove the cancer with clear margins (R0 resection) **You may NOT be eligible if...** - Your cancer has already spread to distant organs - You have had prior chemotherapy or radiation for rectal cancer - You have serious nerve damage or other conditions that make the drugs unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFOLFOXIRI

Irinotecan165 mg/m2、Oxaliplatin85 mg/m2、Left-calcium leucovorin 200mg/㎡,Intravenous infusion,first day. Then, 5-FU 1600 mg/m2/d×2 continuous intravenous infusion(total 3200 mg/m2,infusion 46 hours)in the next two days. Repeat every 14 days.

DRUGXELOX

XELOX consisting of 130 mg/m2 oxaliplatin administered intravenously on day 1 and 1,000 mg/m2 capecitabine administered orally twice daily on days 1-14 for a 3-week cycle.

OTHERChemoradiotherapy

Chemotherapy: oral capecitabine(1650 mg/m2)twice daily during radiotherapy without weekend breaks. Radiation: Radiation therapy is administered via intensity-modulated radiation therapy (IMRT) with a linear accelerator, 6MV-X ray. The patients are scheduled to receive a GTV expanding 6mm to form PTV1 and CTV expanding 6mm to form PTV2. The dose of PTV1 is 50Gy/25 times for 35 days and the dose of PTV2 is 45Gy/25 times for 35 days. Patients were treated in consecutive days per week for a total of 5 weeks.

PROCEDURETME operation

TME operation

PROCEDUREefficacy evaluation

chest/ abdominal CT、pelvic nuclear magnetic resonanceimaging、transrectal ultrasonography


Locations(2)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, China

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT03671252


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