Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Nov 17, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether adjuvant chemotherapy, which is additional treatment after surgery, is necessary for patients with local advanced colorectal cancer (CRC) who have undergone preoperative therapies. The researchers are particularly interested in patients whose cancer has been evaluated as pT0-3N0M0 after these treatments. The goal is to find out if these patients really need the extra chemotherapy or if the initial treatments were enough to reduce the cancer effectively.

To be eligible for the trial, participants need to have been diagnosed with stage III colorectal cancer and must have undergone surgery that shows no high risk of the cancer coming back. Participants should be between the ages of 65 and 74 and must be able to understand and sign consent forms. During the trial, participants can expect close monitoring and support as researchers gather information about the effectiveness of the treatments. It's important to note that people with certain serious health conditions, other cancers, or those who are pregnant or breastfeeding cannot participate in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • preoperative clinical tumor stage III （TxN1-2M0）CRC
• • pathological proved CRC adenocarcinoma by endoscopic biopsy
• • Post operational pathological T0-3N0M0 without high risk factors of recurrence
• • Patient able to understand and sign written informed consent
• Exclusion Criteria:
• • Other malignant tumors history.
• • Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses).
• • Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
• • Non resectable lymph node metastasis.
• • American Society of Anesthesiologists (ASA) grading≥ IV and/or, Eastern Cooperative Oncology Group(ECOG) score≥ 2.
• • Physical or psychological dependence.
• • Pregnant or breast feeding women.
• • Not controlled pre-operational infection.
• • Enrolled in other clinical trials within 4 weeks.
• • Other clinical or laboratorial condition not recommended by investigators.