IG-VMAT for Localized Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934685
• Other study ID #: BeijingH-01-RT
• Status: Recruiting
• Phase: Phase 3
• First received: July 11, 2016
• Last updated: November 16, 2016
• Start date: June 2016
• Est. completion date: May 2021

Study information

• Verified date: November 2016
• Source: Beijing Hospital
• Contact: Qiuzi Zhong
• Phone: +86 13810428903
• Email: drzhongqiuzi[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• hypofraction
70 Gy in 28 fractions over 5.6 weeks
• convention
80Gy in 40 fractions over 8 weeks

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical progression free survival	Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.	up to 18 months	Yes
Secondary	Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0		From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT	No
Secondary	Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0		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	No
Secondary	Overall Survival		up to 5 years	No