IG-VMAT for Localized Prostate Cancer

NCT ID: NCT02934685

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostatic Neoplasms radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hypofraction

70 Gy in 28 fractions over 5.6 weeks

Group Type EXPERIMENTAL

hypofraction

Intervention Type RADIATION

70 Gy in 28 fractions over 5.6 weeks

convention

80Gy in 40 fractions over 8 weeks

Group Type ACTIVE_COMPARATOR

convention

Intervention Type RADIATION

80Gy in 40 fractions over 8 weeks

Interventions

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hypofraction

70 Gy in 28 fractions over 5.6 weeks

Intervention Type RADIATION

convention

80Gy in 40 fractions over 8 weeks

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gaofing Li

director of radiotherapy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaofeng Li, director

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

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Beijing Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiuzi Zhong

Role: CONTACT

Phone: +86 13810428903

Email: [email protected]

Facility Contacts

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Gaofeng Li

Role: primary

Other Identifiers

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BeijingH-01-RT

Identifier Type: -

Identifier Source: org_study_id