Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
Rectal Neoplasms
About this trial
This is an interventional treatment trial for Rectal Neoplasms focused on measuring Rectal Neoplasms, Adjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
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.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Observation
5-fluorouracil
5-fluorouracil alone
mFOLFOX6 or CAPOX
Observation for patients with pathological complete response or yp stage I(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)
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 )
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)
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)