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

University of Erlangen-Nürnberg Medical School

Status and phase: Unknown; Phase 3

Conditions: Anal Carcinoma

Treatments: Procedure: Hyperthermia; Drug: 5-Fluorouracil; Drug: Mitomycin C; Radiation: Irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02369939

HYCAN

Details and patient eligibility

About

Randomized study to investigate the efficacy of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.

Full 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).

Enrollment: 118 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

control arm

Active Comparator group

Description:

Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m\^2/d on d1 and 29; 5-Fluorouracil 1000mg/m\^2/d on d1-5, 29-33

Treatment:

Radiation: Irradiation

Drug: Mitomycin C

Drug: 5-Fluorouracil

Experimental arm

Experimental group

Description:

Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m\^2/d on d1 and 29; 5-Fluorouracil 1000mg/m\^2/d on d1-5, 29-33 Hyperthermia: 6

Treatment:

Radiation: Irradiation

Drug: Mitomycin C

Drug: 5-Fluorouracil

Procedure: Hyperthermia