Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy

• Status: Unknown status
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School
• Treatments: Fluorouracil; Mitomycin; Mitomycins

Criteria

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