Clinical trial NCT04110223: Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
Official title: Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Toxicity
Advanced Cancer
Radiosensitivity
Keywords: radiotherapy
radiosensitivity
radiation toxity
NGS
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the study with locally advanced solid tumors undergoing conventional fractionation or preoperative neoadjuvant radiotherapy (except stage IV patients and stage I patients to be treated with SBRT), including lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma and liver cancer

Brief summary: Despite the common application of radiotherapy in cancer treatment, the prediction of radiosensitivity and treatment response has not yet entered the era of precision medicine. Therefore, development of genome-based methods for predicting radiosensitivity and treatment response is a central goal of radiation oncology. In the previous study, the investigators have identified a set of novel potential biomarkers associated with radiosensitivity and recurrence，through correlating patients' genomic profiles with toxicity, disease progression and overall survival after RT.

Detailed description: Researchers have long recognized that individual differences in sensitivity to radiation are caused by genetic variations and implicated multiple key pathways that might explain radiation toxicity. Normal tissue toxicity is a complex trait that involves the combined effect of a multitude of genes and pathways, and also dynamic interactions with the evolving cancer genome. The effect size of any individual factor is likely small. As a consequence, candidate gene approach and genome-wide association studies rarely lead to the identification of genetic determinants of radiation toxicity. Targeted next-generation sequencing (NGS), on the other hand, has become increasingly routine in the clinic and would allow simultaneous assessment of multiple genetic alterations.

Eligibility criteria: Inclusion Criteria:

1. Patients with locally advanced solid tumors (lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma cancer and liver cancer) identified by cytology and pathology;
2. Patients need conventional fractionation and adequate radiotherapy;
3. Age ≥ 18 years old, male and female;
4. Expected survival time ≥ 12 weeks;
5. PS score 0-2 within 2 weeks before admission to the group;
6. There are tumor tissue samples and blood samples can be used for NGS inspection;
7. Patients volunteered to join this study, sign informed consent, provide all diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, cooperate with follow-up.

Exclusion Criteria:

1. The patient's previous radiation therapy leads to overlapping potential fields;
2. Stage IV patients and stage I patients to be treated with SBRT
3. The patient cannot receive regular imaging examinations;
4. Any serious or uncontrolled signs of systemic disease that the investigator believes may significantly affect the patient's risk/benefit balance, including hepatitis B, hepatitis C, and human immunodeficiency virus;
5. The researcher believes that it is not suitable for the group.

Primary outcomes:
measure: TTP
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinming Yu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: