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CAO/ARO/AIO-16

Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolitadion chemotherapy. A prospective Phase II Pilot Trial of the German Rectal Cancer Group  CAO/ARO/AIO-16

Study type: Investigator-driven, multicenter, open, prospective phase II study

 

Population: Patientens with local advanced rectal cancer cUICC (Phase II-III)

 

Primary objective: The primary objective of the study is to estimate the effect of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As primary endpoint, the rate of patients with a clinical complete response (cCR) will be determined. This rate will then be the basis for patient number calculations in a consecutive trial with 3-year loco-regional control as endpoint.

 

Sekundary objectives:

  • Local regrowth rat

  • Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0)

  • Fecal incontinence according to Wexner-Vaizey Score

  • Quality of life according to EORTC QOL-C30 and QOL-CR29

  • Frequency of Low anterior resection syndrome (LARS-scale)

  • Surgical morbidity and complications in patients undergoing surgery

  • Pathological staging, tumor downstaging (assessed by ypTNM findings in relation to initial cTNM staging), tumor regression grading according to Dworak in patients undergoing surgery

  • R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery

  • Rate of sphincter-sparing surgery in patients undergoing surgery

  • Relapse-free survival (local / distant / overall)

  • Overall survival

  • Translational biomarker studies

Inclusion criteria:

  • Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0 – 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
  • Any MRI staged cT3 tumor or any cT1 cN+ or cT2 cN+ with nodal staging according to “SOP MRI”

  • Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.

  • Cross-sectional imaging of the abdomen and chest to exclude distant metastases.

  • Aged at least 18 years. No upper age limit.

  • WHO/ECOG Performance Status ≤ 1

  • Informed consent of the patient

  • Adequate hematological, hepatic, renal and metabolic function parameters:
    - Leukocytes ≥ 3.000/mm^3
    - ANC ≥ 1.500/mm^3
    - Platelets ≥ 100.000/mm^3
    - Hb > 9 g/dl
    - Serum creatinine ≤ 1.5 x upper limit of normal
    - Creatinin-Clearance ≥ 30 ml / min
    - Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of norm

Exclusion criteria:

  • Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy

  • cT4 tumors

  • Positive lateral pelvic lymph nodes (s. SOP MRI)
  • Distant metastases (to be excluded by CT scan of the thorax and abdomen)

  • Preexisting fecal incontinence for solid stool
  • Preexisting peripheral sensory neuropathy with functional impairment
  • Preexisting myelosuppression refleted by a neutrophil count < 2.000/mm^3 and/or platelets < 100.000/mm^3
  • Severe impairment of kidney function with a Creatinin Clearance < 3 ml/min)
  • Prior antineoplastic therapy for rectal cancer

  • Prior radiotherapy of the pelvic region

  • Major surgery within the last 4 weeks prior to inclusion

  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of Treatment

  • Subject (male or female) is not willing to use highly effective methods of contraception according to the “Clinical trial fertility group” recommendations during treatment and for 6 months (male or female) after the end of Treatment

  • On-treatment participation in an interventional clinical study in the period 30 days prior to inclusion

  • Previous or current drug abuse

  • Other concomitant antineoplastic therapy

  • Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder

  • WHO/ECOG Performance Status > 1

  • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment

  • Chronic diarrhea (> grade 1 according NCI CTCAE)

  • Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception:  non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free

  • Known allergic reactions on study medication

  • Known dihydropyrimidine dehydrogenase deficiency

  • Medication inhibitors of the dihydropyrimidine dehydrogenase, such as Brivudin, Sorivudin and its analogues

  • Pernicious anemia or other anemias caused by Vitamin B-12 deficiency

  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial)

  • Additionally for hyperthermia cardiac pacemakers and metal implants in the proximity of the pelvis constitute a criterion for exclusion

 

 

Treatment: Patients receive radiochemotherapy with 5-FU and oxaliplatin followed by consolidation chemotherapy with 5-FU/folinic acid/oxaliplatin. After evaluation of treatment response on d106 patients will either undergo surgical resection in case of residual tumor or non-operative management when a clinical complete response is seen or repeat evaluation after another 3 months in case of a near clinical complete response. In selected cases transanal microscopic microsurgery can be considered as an alternative to radical surgery. Deep regional hyperthermia can be performed additionally during radiochemotherapy.

Status: aktiv

Beginn der Rekrutierung: 15.06.2018

 

EudraCT No.: 2017-003057-42

 

Zentrum im UCT Universitätsklinikum Frankfurt

Prüfer: Prof. Dr. med. Claus Rödel

Stellvertretender Prüfer: Prof. Dr. med. Emmanouil Fokas
Studiensekretariat:
Atefeh Nateghian

Margarita Diaz

Universitätsklinikum Frankfurt/Main

Klinik für Strahlentherapie und Onkologie

Theodor-Stern Kai 7

60590 Frankfurt am Main

Tel: +49 (0)69 6301-4655/ 3742

E-Mail: studien-strahlen@kgu.de

 

Ansprechpartner Leiter der klinischen Prüfung

Dr. Cihan Gani

Hoppe-Seyler-Str. 3

72076 Tübingen, Germany

E-Mail: cihan.gani@med.uni-tuebingen.de

 

 

Sponsor

Förderer ist die Medizinische Fakultät Tübingen im Rahmen des "AKF-Programms" (Angewandte klinische Forschung). Die Fördernummer ist: AKF-Projekt 384-0-0.

Allgemeine Informationen

Direktor:
Prof. Dr. Claus Rödel

Kontakt:
ambulante Patienten
- Chefsekretariat:
Tel.: +49 69 / 6301-5130
Fax: +49 69 / 6301-5091

- Poliklinik:
Tel.: +49 69 / 6301-5914
Fax: +49 69 / 6301-4877

stationäre Patienten
(Konsile, stationäre Übernahme)
Tel.: +49 69 / 6301-5130
Fax: +49 69 / 6301-5091

Oberarzt-Hotline
(Mo-Fr 09:00 - 17:00 Uhr)
Tel.: +49 151 / 17192036

Dienstarzt Strahlentherapie
(Mo-Fr ab 17:00 Uhr
und am Wochenende)
Tel.: +49 151 / 17192035

Anfrage zur stationären Aufnahme
Für Zuweiser:
Tel.: +49 69 / 6301-2227
Für Patienten:
Tel.: +49 69 / 6301-3327

Email: strahlentherapie@kgu.de

Adresse:
Theodor-Stern-Kai 7
60590 Frankfurt am Main

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