Prostate CancerPhase 3NCT02934685
IG-VMAT for Localized Prostate Cancer
A Phase 3 study testing hypofraction and convention in people with Prostate Cancer, run by Beijing Hospital at 1 site in China.
Trial summary
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- hypofraction and convention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to May 2021
- Phase
- Phase 3
- 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 50 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-79
- Histologically confirmed prostate adenocarcinoma
- Clinical stage T1-3N0M0 according to the AJCC 6th edition
- Gleason score must be >5
- KPS >70
- No radical surgery or cryosurgery for prostate cancer
Who cannot join
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
- Evidence of distant metastases
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing
Gaofeng Li, +86 13701062301, lgf6243@163.com
About this study
Official title: A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
- Conditions
- Prostate Cancer
- Being tested
- hypofraction, convention
- Keywords
- Prostatic Neoplasms, radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionRadiation
70 Gy in 28 fractions over 5.6 weeks
conventionRadiation
80Gy in 40 fractions over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| hypofraction | Experimental | 70 Gy in 28 fractions over 5.6 weeks Receives: Radiation: hypofraction |
| convention | Active comparator | 80Gy in 40 fractions over 8 weeks Receives: Radiation: convention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical progression free survival
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
Measured: up to 18 months
Secondary outcomes (3)
Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
Measured: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
Measured: From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT
Overall Survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gaofing Li, Beijing Hospital
- Investigators
- Gaofeng Li, director, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934685
- Sponsor's protocol ID
- BeijingH-01-RT
- Status last verified
- Nov 2016
- First submitted
- 11 Jul 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02934685
- Acronym / sponsor ID
- BeijingH-01-RT
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Neoplasms, radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 17 Oct 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.
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypofraction | Experimental | Radiation: hypofraction70 Gy in 28 fractions over 5.6 weeks |
| convention | Active comparator | Radiation: convention80Gy in 40 fractions over 8 weeks |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50-79
- Histologically confirmed prostate adenocarcinoma
- Clinical stage T1-3N0M0 according to the AJCC 6th edition
- Gleason score must be >5
- KPS >70
Key exclusion criteria (5 listed)
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
- Evidence of distant metastases
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
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 |
|---|---|---|
| hypofraction70 Gy in 28 fractions over 5.6 weeks | Radiation | hypofraction |
| convention80Gy in 40 fractions over 8 weeks | Radiation | convention |
Primary outcome
Biochemical progression free survival
Time frame: up to 18 months
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
3 secondary outcomes
Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
Time frame: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
Time frame: From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT
Overall Survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Gaofeng Li, director principal investigator
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hypofraction and convention in people with Prostate Cancer, run by Beijing Hospital 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 6 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 18 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Qiuzi Zhong (+86 13810428903, drzhongqiuzi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical progression free survival (time frame: up to 18 months). 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 18 Nov 2016.