Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

NCT02909114 | Unknown Phase 2 DMC

• 1 other identifier: CH-GI-096
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer

Conditions

Colorectal Cancer

Keywords

stereotactic boday radiotherapy, oligometastases

Outcome Measures

Primary Outcomes (1)

• local control assessed by RECIST

  3 years

Secondary Outcomes (2)

• >= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0

  from radiotherapy start to complete treatment 90 days

• overall survival

  3 years

Study Arms (1)

Experimental group

EXPERIMENTAL

SBRT for oligometastatases from colorectal cancer objectives

Radiation: Stereotactic body radiotherapy

Interventions

Stereotactic body radiotherapy RADIATION

All patients will undergo planning CT simulation. 4-dimensional CT will be used for tumors in the lungs or liver. For all lesions, the gross tumor volume (GTV) will be defined as the visible tumor on CT and/or MRI imaging +/- PET. A Planning Target Volume (PTV) margin of 3-5 mm will be added depending on site of disease, immobilization, and institutional set-up accuracy. The prescirbe dosage was as following: Lung lesion DT50-60 Gy/5 fractions; liver 50-60Gy/5-8 fractions; brain DT 40Gy/4-5fractions. All will be treated with SBRT

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
• Diagnosis by pathological examination
• Primary lesion is under control by surgery
• Adequate blood counts:
• White blood cell count ≥3.5 x 109/L
• Haemoglobin levels ≥100g/L
• Platelet count ≥100 x 109/L
• Creatinine levels ≤1.0× upper normal limit (UNL)
• Urea nitrogen levels ≤1.0× upper normal limit (UNL)
• Alanine aminotransferase (ALT) ≤1.5× upper normal limit (UNL)
• Aspartate aminotransferase (AST) ≤1.5× upper normal limit (UNL)
• Alkaline phosphatase (ALP) ≤1.5× upper normal limit (UNL)
• Total bilirubin (TBIL) ≤1.5× upper normal limit (UNL)

You may not qualify if:

• Primary lesion is not under control
• Pancreatic carcinoma
• Oligometastases could not be located
• Pregnancy or breast feeding
• Symptoms or history of peripheral neuropathy

Sponsors & Collaborators

• Jing Jin, M.D.: lead

Study Sites (1)

Cancer Hospital Chinese Acadamy of Medical Sciences

Beijing, Beijing Municipality, 10021, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ning Li, Doctor

CONTACT

13810381399; lee_ak@163.com

Jing Jin, Doctor

CONTACT

13601365130; jingjin1025@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 21, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)