Locally advanced primary or locally recurrent rectal cancer MedDRA version: 19.1 Level: PT Classification code 10038051 Term: Rectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10038050 Term: Rectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10038046
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FLUOROURACIL
CAS Number: 51-21-8
Other descriptive name: 5 FLUOROURACIL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. Dr. h. c. Jürgen Schüttler
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Histologically confirmed, locally advanced or recurrent (any recurrence of tumor within the lesser pelvis; resectable or non-resectable) or locally advanced adenocarcinoma of the rectum (UICC stage IIB-IV); distant oligo-metastases may be present. • ECOG-performance status 3,5 x 109/l, Neutrophil granulocytes > 1,5 x 109/l, Platelets > 100 x 109/l, Hemoglobin > 10 g/dl • Sufficient liver function:, Bilirubin 50 ml/min • Signed study-specific consent form prior to therapy • Fertile patients must use effective contraception during and for 6 months after study treatment • Considered fit for oxaliplatin and 5-FU-containing combination chemotherapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 59 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 59
Exclusion criteria
Exclusion criteria: • Pelvic radiotherapy during the last 12 months • Pregnant or lactating/nursing women • Drug addiction • On-treatment participation on other trials • Active intractable or uncontrollable infection • Prior or concurrent malignancy (= 5 years prior to enrolment in study) except rectal cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free • Chronic diarrhea (> NCI CTC-Grad 1) • Chronic inflammatory disease of the intestine • Collagen vascular disease • The presence of congenital diseases with increased radiation sensitivity, for example ataxia teleangiectatica, or similar • Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy • Myocardial infarction within the past 12 months • Congestive heart failure • Complete bundle branch block • New York Heart Association (NYHA) class III or IV heart disease • Known allergic reactions on study medication • Cardiac pacemaker • Disease that would preclude chemoradiation or deep regional hyperthermia • Any metal implants (with exception of non-clustered marker clips) • Psychological, familial, sociological, or geographical condition that would preclude study compliance • Patients deemed technically unsatisfactory for deep regional hyperthermia • Cardiac symptoms (> NCI CTC Grade 1) due to pre-treatment with fluoropyrimidines • Neurological symptoms (> NCI CTC Grade 1) due to pre-treatment with oxaliplatin • Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption • Oral anticoagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To decide upon the feasibility of a multimodal regimen consisting of radiochemotherapy and hyperthermia;Secondary Objective: None;Primary end point(s): Phase I/II (59 pat.) • Feasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT]) • Number of hyperthermia applications by patient Amendment Phase II (additional 51 pat. --> 110 pat.) • Response rate (pCR) according to the RECIST criteria;Timepoint(s) of evaluation of this end point: End of Therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Local progression-free survival • Distant metastasis-free survival (excluding M1 patients) • Overall survival (excluding M1 patients) • Response rate (RECIST criteria) • Rate of curative resections (R0) • Rate of acute and late toxicity according to NCI CTC, and postoperative morbidity ;Timepoint(s) of evaluation of this end point: End of follow up | — |
Countries
Germany
Contacts
Public ContactStudiensekretariat
Universitätsklinikum Erlangen, Strahlenklinik
Outcome results
None listed