Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors

Shandong First Medical University

Status: Unknown

Conditions: Advanced Cancer; Radiation Toxicity; Radiosensitivity

Treatments: Genetic: next generation sequence

Study type: Observational

Funder types: Other

Identifiers

NCT04110223

GBRT-043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 6 patient groups

non-smell cell lung cancer (NSCLC)

Description:

Advanced NSCLC patients receiving radiotherapy or chemo-radiotherapy

Treatment:

Genetic: next generation sequence

Rectal cancer

Description:

Rectal cancer patients receiving neoadjuvant radiotherapy or chemo-radiotherapy

Treatment:

Genetic: next generation sequence

Smell cell lung cancer (SCLC)

Description:

SCLC patients receiving radiotherapy or chemo-radiotherapy

Treatment:

Genetic: next generation sequence

Esophageal cancer

Description:

Esophageal cancer patients receiving radiotherapy or chemo-radiotherapy

Treatment:

Genetic: next generation sequence

Cervical cancer

Description:

Cervical cancer patients receiving radiotherapy or chemo-radiotherapy

Treatment:

Genetic: next generation sequence

Liver cancer

Description:

Liver cancer atients receiving radiotherapy or chemo-radiotherapy

Treatment:

Genetic: next generation sequence