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

• Conditions: Radiation Toxicity; Radiosensitivity; Advanced Cancer
• Interventions: Genetic: next generation sequence

• Registration Number: NCT04110223
• Lead Sponsor: Shandong Cancer Hospital and Institute

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.

Study Timeline

• Study Start: 2018-10-08
• Study First Submitted: 2019-06-12
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-29
• Last Update Submitted: 2019-09-29
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01
• Primary Completion: 2021-10-08
• Study Completion: 2021-10-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervical cancer	next generation sequence	Cervical cancer patients receiving radiotherapy or chemo-radiotherapy
Liver cancer	next generation sequence	Liver cancer atients receiving radiotherapy or chemo-radiotherapy
non-smell cell lung cancer (NSCLC)	next generation sequence	Advanced NSCLC patients receiving radiotherapy or chemo-radiotherapy
Esophageal cancer	next generation sequence	Esophageal cancer patients receiving radiotherapy or chemo-radiotherapy
Rectal cancer	next generation sequence	Rectal cancer patients receiving neoadjuvant radiotherapy or chemo-radiotherapy
Smell cell lung cancer (SCLC)	next generation sequence	SCLC patients receiving radiotherapy or chemo-radiotherapy

Primary Outcome Measures

Name	Time	Method
TTP	2 years	Time to progression
OS	2 years	Time to death

Trial Locations

Locations (1)

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China