Colorectal CancerPhase 2NCT02909114
Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
A Phase 2 study testing Stereotactic body radiotherapy in people with Colorectal Cancer, run by Jing Jin, M.D. at 1 site in China.
Trial summary
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 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
Show all 14Show fewer
- 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)
Who cannot join
- Primary lesion is not under control
- Pancreatic carcinoma
- Oligometastases could not be located
- Pregnancy or breast feeding
- Symptoms or history of peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Acadamy of Medical Sciences
Beijing, Beijing Municipality, 10021
Ning Li, Doctor, 13810381399 ext. 0086, lee_ak@163.com
Jing Jin, 13601365130 ext. 0086, jingjin1025@163.com
About this study
Official title: Phase II Study of Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer
Read the detailed description
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.
- Conditions
- Colorectal Cancer
- Being tested
- Stereotactic body radiotherapy
- Keywords
- stereotactic boday radiotherapy, oligometastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | SBRT for oligometastatases from colorectal cancer objectives Receives: Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control assessed by RECIST
Measured: 3 years
Secondary outcomes (2)
>= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0
Measured: from radiotherapy start to complete treatment 90 days
overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Jin, M.D.
- Responsible party
- Sponsor-investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909114
- Sponsor's protocol ID
- CH-GI-096
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02909114
- Acronym / sponsor ID
- CH-GI-096
- Conditions
- Colorectal Cancer
- Keywords
- stereotactic boday radiotherapy, oligometastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jing Jin, M.D.
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer
Detailed description
Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: Stereotactic body radiotherapySBRT for oligometastatases from colorectal cancer objectives |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18-75 years
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
- Diagnosis by pathological examination
- Primary lesion is under control by surgery
- Adequate blood counts:
Key exclusion criteria (5 listed)
- Primary lesion is not under control
- Pancreatic carcinoma
- Oligometastases could not be located
- Pregnancy or breast feeding
- Symptoms or history of peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapyAll 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 | Radiation | Experimental group |
Primary outcome
local control assessed by RECIST
Time frame: 3 years
2 secondary outcomes
>= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0
Time frame: from radiotherapy start to complete treatment 90 days
overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiotherapy in people with Colorectal Cancer, run by Jing Jin, M.D. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, Doctor (13810381399 ext. +86, lee_ak@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control assessed by RECIST (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.