Clinical trial NCT03573791: Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
Official title: Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Cancer of Rectum
Cancer of the Rectum
Neoplasms, Rectal
Rectal Tumors
Rectum Cancer
Rectum Neoplasms
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.

Brief summary: Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.

Detailed description: According to postoperative pathological examination results, all participants will be divided into two groups: complete response (ypT0N0) and poor response (\>ypT1-2N0). Differentially expressed genes between complete response and poor response will be analyzed. A scoring formula will be established based on the results. Tumor tissue samples are collected before neoadjuvant therapy and will be analyzed via RNA sequencing.

Eligibility criteria: Inclusion Criteria:

* Histopathology proved to be adenocarcinoma of the rectum.
* The edge of tumor is within 12cm of anus margin.
* According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2.
* There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy.
* Understand and agree to sign the informed consent for the study.

Exclusion Criteria:

* With intestinal obstruction or impending obstruction, or perforation.
* With other malignancies occurred within 5 years.

Primary outcomes:
measure: Comparing gene expression differences between poor response group and complete response group by using RNA sequencing.
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 3 years
measure: Progression Free Survival(PFS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Zheng Wang, MD/PhD
role: STUDY_CHAIR
References:
citation: Chang GJ, Park IJ, You YN, et al. Neoadjuvant treatment response and outcomes in locally advanced rectal cancer: Establishing oncologic benchmarks. Journal of Clinical Oncology 29(15):3545-3545,2011.