NCT03748485 Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
| NCT ID | NCT03748485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 650 participants |
| Start Date | 2019-04-30 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 650 participants in total. It began in 2019-04-30 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Jun Huang, MD/PHD
STUDY CHAIR
sixth affiliate hospital of Sun yatsen Hospital
Frequently Asked Questions
Who can join the NCT03748485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03748485 currently recruiting?
Yes, NCT03748485 is actively recruiting participants. Contact the research team at wangjpgz@126.com for enrollment information.
Where is the NCT03748485 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT03748485 clinical trial?
NCT03748485 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. The principal investigator is Jun Huang, MD/PHD at sixth affiliate hospital of Sun yatsen Hospital. The trial plans to enroll 650 participants.
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