Anal Carcinoma
Conditions
Keywords
anal carcinoma, hyperthermia, radiotherapy, chemotherapy, radiochemotherapy
Brief summary
Randomized study to investigate the efficacy of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.
Detailed description
Pat. with anal carcinoma and treated with standard radiochemotherapy with Mitomycin C and 5-FU will in the experimental arm receive deep regional hyperthermia (6x).
Interventions
RADIATIONIrradiation
Radiotherapy 55,8 Gy - 59,4 Gy
DRUGMitomycin C
MMC w1, w5
DRUG5-Fluorouracil
5-FU w1, w5
PROCEDUREHyperthermia
6x deep regional hyperthermia
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven anal squamous cell carcinoma (SCC) (WHO 2004), including anal canal carcinoma (UICC 2002) and anal margin carcinoma (UICC 2002) * All stages except T1 N0 M0 after local excision (UICC 2002) * Age ≥ 18 years * ECOG Status 0-1 * Patients that have understand protocol and signed informed consent form * Sufficient bone marrow function: WBC ≥ 3,0 x 10\^9/l, Platelets ≥ 100 x 10\^9/l, Hemoglobin ≥ 10 g/dl * Sufficient liver function: Bilirubin \< 1,5 mg/dl, SGOT, SGPT, alkaline phosphatase, gGT less than 3 times upper limit of normal
Exclusion criteria
* Stage T1 N0 M0 after local excision (UICC 2002) * Uncontrolled, severe cardiac dysfunction (NYHA III/IV) * 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 * Chronic inflammatory disease of the intestine * Active intractable or uncontrolled infection * Chronic diarrhea ( \> NCI CTC-Grad 1) * Acute thrombosis * Collagen vascular disease * Cardiac pacemaker * HIV-infection; Patients with hepatitis A or B virus infection, with HPV infection or Patients receiving immune suppressive treatment can be included * Devices that preclude deep regional hyperthermia (Endoprosthesis, stent in vascular system, acute thrombosis) * Any metal implants (with exception of non-clustered marker clips) * Conditions that preclude the application of fractionated pelvic radiotherapy * Conditions that preclude regular follow-up * Pregnant or breast feeding women * Prior pelvic radiotherapy * Prior chemotherapy * Drug addiction * On-treatment participation on other trials * Prior or concurrent malignancy or leucemia (≤ 5 years prior to enrolment in study) except anal cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free * The presence of increased radiation sensitivity, for example ataxia teleangiectatica, or similar * Psychological, familial, sociological, or geographical condition that would preclude study compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of complete remission | 12 weeks after start of treatment |
Secondary
| Measure | Time frame |
|---|---|
| locoregional relapse-free survival | 5 years after start of treatment |
| Overall relapse-free survival | 5 years after start of treatment |
| Overall survival | 5 years after start of treatment |
| Colostomy-free survival | 5 years after start of treatment |
| Rate of acute and late toxicity | 5 years after start of treatment |
| Quality of life | 5 years after start of treatment |
| Response rate | 5 years after start of treatment |
Countries
Germany
Contacts
Primary ContactRainer Fietkau, Prof. Dr.
Outcome results
None listed