IG-VMAT for Localized Prostate Cancer

NCT02934685 | Unknown Phase 3 DMC

• 1 other identifier: BeijingH-01-RT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostatic Neoplasms; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

• Overall Survival

  up to 5 years

Study Arms (2)

hypofraction

EXPERIMENTAL

70 Gy in 28 fractions over 5.6 weeks

Radiation: hypofraction

convention

ACTIVE COMPARATOR

80Gy in 40 fractions over 8 weeks

Radiation: convention

Interventions

hypofraction RADIATION

70 Gy in 28 fractions over 5.6 weeks

hypofraction

convention RADIATION

80Gy in 40 fractions over 8 weeks

convention

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Gaofeng Li, director

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiuzi Zhong

CONTACT

+86 13810428903; drzhongqiuzi@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of radiotherapy department

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: October 17, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: May 1, 2021
• Last Updated: November 18, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)