Trial document





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

  DRKS00003645

Trial Description

start of 1:1-Block title

Title

Prospective Randomised Multicenter Phase-III-study: Preoperative Radiochemotherapy and Adjuvant Chemotherapy With 5-Fluorouracil Plus Oxaliplatin Versus Preoperative Radiochemotherapy and Adjuvant Chemotherapy With 5-Fluorouracil for Locally Advanced Rectal Cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Standard treatment for locally advanced cancer of the rectum is preoperative
chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy
with 5-FU. According to our previous study (CAO/ARO/AIO-94, published in the New England
Journal of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures,
yet, still 36% of all patients develop distant metastasis. Therefore, our new study
(CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve
the control of distant metastases. It is our hypothesis that the rate of disease free
survival will improve by 5 to 8% after 3 years of follow-up.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003645
  •   2012/11/30
  •   2006/07/05
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00349076  (ClinicalTrials.gov)
  •   CAO/ARO/AIO-04  (University of Erlangen-Nürnberg Medical School)
  •   German Cancer Aid (no. 106759) 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Rectal Neoplasms
  •   C20 -  Malignant neoplasm of rectum
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: 5-FU and oxaliplatin
  •   Drug: 5-FU
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Disease free survival at 3 years defined as the interval from randomization to locoregional or metastatic recurrence or the appearance or a secondary colorectal cancer or death, whichever occurs first.; time frame: 3 years

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Resection rate, rate of sphincter preservation, tumor regression, cumulative incidence of local and distant recurrences, overall survival, toxicity, quality of life; time frame: 5-year follow up

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2006/07/31
  •   1200
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Minimum age: 18 years

- Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from
the anal verge, with clinically staged T3/4 or any node-positive disease

- No prior therapy except a diverting stoma

- ECOG PS less than or equal 2

- Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count >
1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl

- Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline
phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance
> 50 ml/min

- Written informed consent before randomization

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Pregnant or breast feeding women

- Fertile patients without adequate contraception during therapy

- Past or ongoing drug abuse or alcoholic excess

- Prior chemotherapy

- Prior radiotherapy to the pelvis

- Prior (within 4 weeks) or concurrent treatment with any other investigational agent

- Psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule

- History of severe somatic or psychological diseases: - instable cardiac disease not
well controlled with medication, myocardial infarction within the last 6 months:*
Central nervous system disorders or psychiatric disability including dementia or
epileptic disease; * active uncontrolled intercurrent infections or sepsis

- Peripheral neuropathy > 2 (NCI CTC AE grading)

- Previous or concurrent malignancies, with the exception of adequately treated basal
cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of
patients with other adequately treated tumors within the last 5 years has to be
discussed with the principal investigator

- Chronic diarrhea (> NCI CTC AE-Grad 1)

- Known allergy to substances containing platinum compounds

- Concurrent use of the antiviral agent sorivudine or chemically related analogues

- Known deficiency of dehydropyrimidindehydrogenase (DPD)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Erlangen-Nürnberg Medical School
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Dept. of Radiation Therapy, University of Erlangen, Germany
    • Rolf Sauer, M.D. 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Dept. of Radiation Therapy, University of Erlangen, Germany
    • Rolf Sauer, M.D. 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

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
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
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 .
  •   27
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.