Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006440

Trial Description

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Title

Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial

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Trial Acronym

PLATIN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

For patients with prostate cancer and a high risk of lymph node involvement or confirmed
pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option.
However, conventional radiotherapy of the pelvis has limited by gastrointestinal and
urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy
of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose
is given during each session to the prostate or the prostate bed and to confirmed lymph node
metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are
required, and continuation during radiotherapy and for a further two years are strongly
recommended.

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Brief Summary in Scientific Language

The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1:
Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the
prostate.

Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3:
Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the
prostate bed.

Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with
previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage
above the previous treatment fields with integrated boost to macroscopic lymph node
metastases.

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Organizational Data

  •   DRKS00006440
  •   2015/01/09
  •   2013/07/16
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT01903408  (ClinicalTrials.gov)
  •   Klaus Tschira 00.153.2009  (Heidelberg University)
  •   ARO 2009-05 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Rate of safe feasibility (SDR); time frame: 2 years; Proportion of treatments begun as planned without grade 3-4 NCI common toxicity criteria adverse events (CTC AE) or treatment disruption among all patients that fulfill inclusion criteria and have been treated according to trial protocol for at least a week.

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Secondary Outcome

- Biochemical recurrence free survival; time frame: 2 years
- Quality of Life; time frame: 2 years; Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2009/05/31
  •   200
  •   [---]*
  •   [---]*
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Inclusion Criteria

  •   Male
  •   2   Years
  •   5   Years
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Additional Inclusion Criteria

- histologically confirmed prostate cancer with Gleason Score

- risk of lymph node involvement >20% (according to Roach Formula), pelvic lymph node
metastases in CT/MRI or histologically confirmed lymph node involvement

- Karnofsky Index >/= 70%

- age 18-75 years

- neoadjuvant antihormonal treatment for 2 months, continuation until the end of
radiotherapy

- written informed consent

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Exclusion Criteria

- stage IV (distant metastases)

- lymph node metastases outside the pelvis

- rising prostate-specific antigen (PSA) under antihormonal treatment

- severe wound complications after laparatomy

- severe lymph edema of the legs, elephantiasis, postthrombotic syndrome

- decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system
or kidneys, coagulopathy

- history of other malignancy within the last 5 years (except for basal cell carcinoma
or squamous carcinoma of the skin)

- previous irradiation of the pelvic lymph nodes

- concurrent participation in a clinical trial that might influence the results of
either trial

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Addresses

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    • Heidelberg University
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Klaus Tschira Stiftung gGmbH
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • University Hospital Heidelberg, Department of Radiation Oncology
    • Klaus Herfarth, Prof. Dr. 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Renate Haselmann 
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.