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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • wait and watch
  • adjuvant chemotherapy

Treatment groups

650 Participants
are divided into 2 treatment groups