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

University of Erlangen-Nürnberg Medical School

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Rectal Cancer

Treatments

Radiation: Radiotherapy

Drug: Capecitabine

Drug: Oxaliplatin

Procedure: Hyperthermia

Drug: 5-Fluorouracil

Study type

Interventional

Funder types

Other

Identifiers

NCT01716949

ESHO201107/001

Details and patient eligibility

About

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.

Enrollment

59 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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