Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
Recruiting · NCT03748485 · Interventional (participants receive a specific treatment) · Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis.
Who can take part
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.
Where it is running
1 location listed.
- Sixth Affiliated Hospital of Sun Yat-sen University - Guangzhou, Guangdong, China