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A PHASE II TRIAL OF HYPOFRACTIONATED INTENSITY MODULATED RADIOTHERAPY FOR PROSTATE CANCER

A PHASE II TRIAL OF HYPOFRACTIONATED INTENSITY MODULATED RADIOTHERAPY FOR PROSTATE CANCER

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-11001531
Enrollment
Unknown
Registered
2011-07-13
Start date
2008-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

localized prostate cancer

Interventions

Total:Intensity-modulated Radiotherapy: 2.7GyX25 fractions to the prostate +/- seminal vesicle +/- prophylactic pelvis lymphnode irradiation (concurrent with 50Gy/25 fractions).

Sponsors

Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Signed informed agreement form; 2. Pathologic confirmed to be prostate adenocarcinoma; 3. Localized disease without extension beyond pelvis; 4. Aged between 50 and 75 years, with Karnofsky score>70; 5. Hgb>=10 g/dl, WBC>=3.5*10^9/L, PLT>=85*10^9/L; 6. AST, ALT and TB<=1.5 normal value, Cr and BUN<=1.0 normal value; 6. Without life-threatening comorbidites.

Exclusion criteria

Exclusion criteria: 1. Having a history of other malignancy (except tumor in situ); 2. Having a history of radiotherapy to the abdomen or pelvis; 3. Concurrent with severe infection or other serious acute diseases; 4. With other uncontrollable complications; 5. Life expectancy< 6 months; 6. Already participating in other clinical trial within 4 weeks; 7. With other potential unfitting conditions which may conflict the clinical trial.

Design outcomes

Primary

MeasureTime frame
T-PSA and F-PSA;the acute and late gastrointestinal (GI) and genitourinary (GU) toxicity;bNED;

Countries

China

Contacts

Public ContactYueping Liu
yuepingliu8@hotmail.com+86 010 87787639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026