Efficacy of Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Pathology-oriented, Prospective, Multicenter, Randomized, Open-label, Parallel Group Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Capecitabine
- Conditions
- Rectal Neoplasms
- Sponsor
- LI XIN-XIANG
- Enrollment
- 764
- Locations
- 1
- Primary Endpoint
- Disease free survival
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.
Detailed Description
Previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. Moreover, the local control was not responsible for survival benefit. Adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. However, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. At present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. Besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
Investigators
LI XIN-XIANG
Professor
Fudan University
Eligibility Criteria
Inclusion Criteria
- •The lesion must be within 12 cm of the anus as measured by endoscopy
- •Histologically confirmed diagnosis of rectal carcinoma
- •CT, MRI and EUS verified as clinical stage III rectal cancer without involvement of other organs
- •Without multiple primary cancer
- •Sufficient organ function
- •Able to provide written informed consent
Exclusion Criteria
- •Younger than 18 years or older than 75 years
- •Synchronous or metachronous malignancy within 5 years.
- •Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
- •Patients with a history of pelvic irradiation.
- •ASA grade IV or V.
- •Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding.
- •Severe mental illness.
- •Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
- •Patients who received steroid therapy within one month.
- •Patients or family members misunderstand the conditions and goals of this study.
Arms & Interventions
5-fluorouracil
Capecitabine for patients with pathological complete response or yp stage I Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil )
Intervention: Capecitabine
5-fluorouracil alone
5-fluorouracil alone for patients with yp stage II or III Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone)
Intervention: Capecitabine
mFOLFOX6 or CAPOX
Oxaliplatin combined with 5-fluorouracil for patients with yp stage II or III mFOLFOX6 (leucovorin 400 mg/m2 as a 2-hour infusion, and the concurrent administration of oxaliplatin 85 mg/m2 as a 2-hour infusion, followed by a bolus of 5-FU 400 mg/m2 within 15 min and 46-hour infusion of 5-FU 2400 mg/m2 on day 1 every 2 weeks), three cycles or CAPOX (oxaliplatin 130 mg/m2 as a 2-hour infusion on day 1, followed by capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks), three cycles( According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone)
Intervention: mFOLFOX6 or CAPOX
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 3-year
Calculated from the date of surgery to the date of recurrence
Secondary Outcomes
- Overall survival(3-year, 5-year)
- The rate of adverse events resulted from chemotherapy(3-year)
- The quality of life postoperatively(3-month, 6-month, 9-month, 12-month, 18-month, 24-month)
- Disease free survival(5-year)
- The rate of local recurrence(3-year)