Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577808
• Other study ID #: FDRT-R008
• Status: Recruiting
• Start date: August 17, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: August 2018
• Source: Fudan University
• Contact: Lijun Shen, MD
• Phone: 86-2164175590
• Email: lijunshen[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 1, 2020
• Est. primary completion date: August 1, 2020
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• pathological confirmed adenocarcinoma

• clinical stage T3-4 and/or N+

• the distance from anal verge less than 12 cm

• without distance metastases

• KPS >=70

• without previous anti-cancer therapy

• sign the inform consent

Exclusion Criteria:

• pregnancy or breast-feeding women

• serious medical illness

• baseline blood and biochemical indicators do not meet the following criteria:

neutrophils=1.5×10^9/L, Hb=90g/L, PLT=100×10^9/L, ALT/AST =2.5 ULN, Cr= 1 ULN

Related Conditions & MeSH terms

• Chemoradiation
• Organoids
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• Biopsy
Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.

Locations

Country	Name	City	State
China	Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhen Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.	The investigators will culture rectal cancer organoids and treat with irradiation and the same chemotherapy drugs as the corresponding patient. The number and size of alive organoids will be observed after treatment. The correlation of organoids sensitivity and patient response will be evaluated.	2018.08-2020.11
Secondary	Response of the rectal cancer patients to neoadjuvant chemoradiation.	The investigators will use pathological tumor regression grade (TRG) to evaluate chemoradiation response of locally advanced rectal cancer patients.	2018.08-2020.11