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Spots Global Cancer Trial Database for Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose

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Trial Identification

Brief Title: Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose

Official Title: Phase III Study for Prostate Cancer, Randomizing Between Two Radiation Dose Levels (68 Gy vs. 78 Gy) and Utilizing Three Dimensional Conformal Radiotherapy

Study ID: NCT00692107

Interventions

Gray
Gray

Study Description

Brief Summary: 3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. There are retrospective and preliminary prospective reports of a better local control / disease free survival (including PSA control) using higher tumor doses. A prospective randomised phase III study is required to validate these reports. The purpose of this randomized phase III study is to investigate and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and 78 Gy;

Detailed Description: Patients were stratified by hospital, treatment group, age and (neo)adjuvant hormonal therapy. Four treatment groups with specific radiation volumes were defined depending on the estimated risk of tumour involvement of the seminal vesicles (based on T-stage, initial PSA and Gleason Score or Differentiation Grade).The dose was delivered with daily fractions of 2 Gy, five times a week. The total duration of the treatment was 7 weeks for patients treated to 68 Gy and 8 week for 78 Gy. Objectives: * To test in a phase III randomised study the hypothesis that higher radiation doses lead to a higher freedom from failure rate for localized prostate cancer. * To test the hypothesis that a higher freedom from failure rate leads to a longer disease-free survival and overall survival. * To limit acute and late toxicity with respect to gastro-intestinal and urological toxicity. * To evaluate different PSA related endpoints for local failure and distant metastasis. * To establish a database of patients treated to escalated doses with Dose Volume Histograms of the normal tissues at risk for each individual patient and common toxicity endpoints. * To validate a model to estimate normal tissue complication probabilities (NTCPs) of rectum and bladder, based on the above-mentioned database, and to obtain reliable parameter values for NTCP estimations.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

The Netherlands Cancer Institute, Amsterdam, , Netherlands

Radiotherapeutic Institute Friesland, Leeuwarden, , Netherlands

Daniel Den Hoed Cancer Center, Rotterdam, , Netherlands

Zeeuws Radiotherapeutic Institute, Vlissingen, , Netherlands

Contact Details

Name: Joos V Lebesque, MD, PhD

Affiliation: The Netherlands Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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