Trial document





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

  DRKS00010742

Trial Description

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Title

Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial

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Trial Acronym

HT01

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The current trial is evaluating the impact of deep regional hyperthermia on the pathological
complete response rate in locally advanced rectal cancer in the context of preoperative 5FU
based radiochemotherapy.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00010742
  •   2016/06/30
  •   2014/12/02
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02353858  (ClinicalTrials.gov)
  •   HT01  (University Hospital Tuebingen)
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Health Condition or Problem studied

  •   Rectal Cancer
  •   Locally Advanced Rectal Cancer
  •   Hyperthermia
  •   Hyperthermic Radiochemotherapy
  •   Hyperthermic Chemoradiotherapy
  •   Deep Regional Hyperthermia
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Other: Deep regional hyperthermia
  •   Radiation: Radiotherapy
  •   Drug: Chemotherapy (5-Fluorouracil)
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

- Pathological complete response rate; time frame: After surgical resection (4-6 weeks after last radiotherapy fraction)

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Secondary Outcome

- Locoregional progression free survival; time frame: 3 years
- Disease free survival; time frame: 3 years
- Distant metastases free survival; time frame: 3 years
- Overall survival; time frame: 3 years
- Number of hyperthermia treatments; time frame: At completion of hyperthermic radiochemotherapy
- Acute and chronic treatment related toxicity, according to CTC criteria; time frame: 3 years
- post operative morbidity; time frame: 3 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2012/08/31
  •   78
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Inclusion criteria:

- Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal
verge)

- International Union Against Cancer stages II or III

- ECOG PS 0/2

- Informed consent

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Exclusion Criteria

Exclusion Criteria:

- Congestive heart failure (NYHA III/IV)

- History of myocardial infarction within the last 6 months.

- AV Block III

- Total hip replacement or major metal pelvic implants

- Cardiac pacemaker

- Contraindications for radiochemotherapy

- Contraindications for surgical tumor resection

- Previous pelvic radiotherapy or chemotherapy

- Active chronic inflammatory bowel disease

- Collagenosis

- Congenital diseases with increased radiosensitivity

- Pregnancy or breastfeeding

- Secondary malignancies other than locally controlled basalioma or in-situ carcinomas
Infiltration of the anal canal

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Addresses

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    • University Hospital Tuebingen
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    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Daniel Zips, MD, Prof 
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  • start of 1:1-Block address public-contact
    • Daniel Zips, MD, Prof 
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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 .
  •   2
  •   2016/06/22
* This entry means the parameter is not applicable or has not been set.