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A Phase II Clinical Study Based on Body Stereotactic Radiotherapy (SBRT) in Patients with Colorectal Cancer Oligometastasis or Oligoprogression of Lung (SBRT-CR01)

A Phase II Clinical Study Based on Body Stereotactic Radiotherapy (SBRT) in Patients with Colorectal Cancer Oligometastasis or Oligoprogression of Lung

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071216
Enrollment
Unknown
Registered
2023-05-08
Start date
2023-05-15
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

Treatment group:Stereotactic Body Radiation Therapy

Sponsors

Department of Radiation Oncology, Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. ECOG 0-1 level; 3. Pathological diagnostic criteria: primary lesion was diagnosed as colorectal adenocarcinoma by histopathology and/or cytology; 4. It was confirmed by imaging or pathological examination as lung metastasis, and it was confirmed as oligometastasis (metastatic sites 5, but progression or new metastatic foci did not exceed 5 during systemic treatment, while other metastases did not progress after systematic treatment); After multidisciplinary discussion (MDT), SBRT treatment of lung metastasis was recommended; 5. No other serious medical complications; 6. Clear consciousness, can cooperate with positioning, positioning, treatment; 7. The intensity-modulated radiotherapy plan design meets the dosimetry requirements; 8. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and were willing to accept follow-up; 9. No history of chest radiotherapy; 10. Vital organs or functions meet the following requirements (no blood components or cell growth factors are allowed to be used for correction within 2 weeks before the examination date) : (1) Absolute count of neutrophil granulocyte (ANC) >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=10g/dL; (2) Serum albumin >=3.0 g/dL, total bilirubin =2cm; 12. Previous treatment: For subjects with oligometastasis, no systematic treatment should be received after diagnosis of oligometastasis; for subjects with oligoprogression, previous treatment with more than second-line systematic treatment indicates the existence of oligoprogression; 13. Women of childbearing age must undergo serum HCG tests within 7 days prior to SBRT treatment and must voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last dose of chemoracal therapy; For males, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and within 8 weeks after the last dose of chemoradiotherapy.

Exclusion criteria

Exclusion criteria: 1. Patients with prior or concurrent malignant tumors, with the exception of fully treated basal cell carcinoma of skin, early thyroid cancer, breast cancer, lymphoma and other tumors with excellent prognosis; 2. Survival is predicted to be less than 3 months; 3. Complicated with severe interstitial pulmonary disease or obstructive pulmonary disease; 4. Breastfeeding or pregnancy; 5. Psychiatric or medical factors prevent the patient from knowing; 6. Patients judged by the investigator to have poor compliance or not suitable for the clinical trial; 7. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 8. Active hepatitis B (HbsAg positive and HBV-DNA>=2500 copies /ml or 500IU/ml) or hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of assay); Hepatitis B and hepatitis C infection (HbsAg or HbcAb positive and HCV antibody positive); 9. Participate in other interventional clinical trials currently or before enrollment.

Design outcomes

Primary

MeasureTime frame
Objective response rate (Based on the 2nd assessment of outcome after SBRT);

Secondary

MeasureTime frame
Rate of new metastases in the lungs;Toxicity;

Countries

China

Contacts

Public ContactWang Weihu

Beijing Cancer Hospital

wangweihu88@163.com+86 13611396920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026