Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

NCT03577808 | Unknown

• 1 other identifier: FDRT-R008
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Organoids; Rectal Cancer; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response of the rectal cancer patients to neoadjuvant chemoradiation.

  2018.08-2020.11

Study Arms (1)

Arm

Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice. Organoids bio-bank of pre-treatment tumor biopsies will be established and exposed to irradiation and the same chemotherapy drugs as the corresponding patient.

Other: Biopsy

Interventions

Biopsy OTHER

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

Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhen Zhang: lead

Study Sites (1)

Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Zhen Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Guoqiang Hua, PhD

  Institute of Radiation Medicine, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijun Shen, MD

CONTACT

86-2164175590; lijunshen@fudan.edu.cn

Zhen Zhang, MD

CONTACT

86-2164175590; zhen_zhang@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Zhang

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 5, 2018
• Study Start: August 17, 2018
• Primary Completion: August 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

CN (1)