Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
ConditionColorectal Neoplasms Malignant
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
The goal of this clinical trial is to investigate the effectiveness of localized interventions in improving the 5-year survival rate for colorectal cancer patients with ≥10 liver metastases. We aim to answer the following question:
Can localized interventions, including surgery and/or ablation and/or stereotactic body radiotherapy (SBRT), enhance the 5-year survival rate compared to palliative chemotherapy alone in patients with ≥10 colorectal liver metastases (CRLM)?
Participants in this study, who have achieved disease control through chemotherapy, will undergo either localized interventions (surgery and/or ablation and/or SBRT) or receive palliative chemotherapy alone. Researchers will compare the survival outcomes between these groups to determine the potential benefits of localized interventions for patients with ≥10 CRLM.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Histologically confirmed colorectal adenocarcinoma.
Baseline imaging (CT, MRI, or PET/CT as necessary) or pathological confirmation of liver metastasis, with no extrahepatic metastasis (consideration for inclusion may be given to lesions with a diameter less than 10mm in the lungs or lymph nodes if metastasis is difficult to confirm or is suspected).
Disease control (PR or SD) achieved after a minimum of 8 cycles of systemic chemotherapy.
Disqualifiers
Definite presence of extrahepatic metastasis and/or primary tumor not amenable to curative surgical resection.
Severe arterial embolism or ascites.
Bleeding tendencies or coagulation disorders.
Hypertensive crisis or hypertensive encephalopathy.
Trial design
Treatments tested in this trial
- Surgical resection and/or ablation therapy and/or SBRT
- Palliative Chemotherapy
Treatment groups
117 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov