NCT05797467RecruitingPhase 3
Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail
Source: ClinicalTrials.gov · Last updated 24 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial\] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) compared to adjuvant chemotherapy alone.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 366 (estimated)
- First submitted
- 20 Mar 2023
- Start date
- 1 Apr 2023
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT05797467
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 366
- From 1 Apr 2023 to the primary completion date, 1 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
Other illness
- A history of other malignant tumors;
- Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
- Patients allergic to any component in the study;
- Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
- Patients with a history of severe mental illness;
Lab values
- Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests;
- Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.
Other
- Pregnant or lactating women;
Who the study is looking for
- Both sexes, aged 18-75 years;
- Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
- ASA grade \< IV and/or ECOG performance status score ≤ 2 points;
- Fully understand and voluntarily sign the informed consent form for this study.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliate Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.