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Rectal Cancer | Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer

Rectal Cancer research study

What is the primary objective of this study?

This trial examines the feasibility, effectiveness and safety of a combination of radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively improved tumor regression allowing less aggressive surgery in primary locally advanced rectal cancer and a higher rate of curative resections in heavily pretreated locally recurrent rectal cancers. Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates, and toxicity. It is planned to include a total number of 59 patients over a period of 2.5 years.

Who is eligible to participate?

Inclusion Criteria: - Age ≥ 18 years - Histologically confirmed, locally advanced or recurrent (any recurrence of tumor within the lesser pelvis; resectable or non-resectable) adenocarcinoma of the rectum (UICC stage IIB-IV); distant oligo-metastases may be present. - ECOG-performance status < 2 - Sufficient bone marrow function: - WBC > 3,5 x 10^9/l - Neutrophil granulocytes > 1,5 x 10^9/l - Platelets > 100 x 10^9/l - Hemoglobin > 10 g/dl - Sufficient liver function: Bilirubin < 2,0 mg%, SGOT, SGPT, alkaline phosphatase, gGT less than 3 times upper limit of normal - Serum creatinine < 1,5 mg%, glomerular filtration rate (or comparable test) > 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 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 teleangiectatic ataxia, 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 CTCAE Grade 1) due to pretreatment with fluoropyrimidines - Neurological symptoms (> NCI CTCAE Grade 1) due to pretreatment with oxaliplatin - Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption - Oral anticoagulation

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Rectal Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:Radiotherapy45 up to 50.4 Gy; daily dose 1,8 Gy, 5 days per weeks

Procedure:Hyperthermia10 sessions, therapeutic time 60 min

Drug:5-Fluorouracil250 mg/m^2/d as continuous i.v. infusion on d1-14, 22-35 (may be preplaced by Capecitabine)

Drug:Capecitabine1650 mg/m^2/d oral intake d1-14, 22-35 (may be replaced by 5-Fluorouracil)

Drug:Oxaliplatin50 mg/m^2/d as 2-hour bolus infusion on d2, 9, 23, 30

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HyRecRadiotherapy, Hyperthermia, 5-Fluorouracil (may be replaced by Capecitabine), Capecitabine (may be replaced by 5-Fluorouracil), Oxaliplatin

Study Status

Recruiting

Start Date: September 2012

Completed Date: June 2023

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Feasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT])

Secondary Outcome: Local progression-free survival

Study sponsors, principal investigator, and references

Principal Investigator: Oliver Ott, MD

Lead Sponsor: University of Erlangen-Nürnberg Medical School

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01716949

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