Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LI XIN-XIANG
• Treatments: Capecitabine; Fluorouracil; Leucovorin; Oxaliplatin

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.