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

Phase 3

• Conditions: Anal Carcinoma
• Interventions: Radiation: Irradiation; Drug: Mitomycin C; Drug: 5-Fluorouracil; Procedure: Hyperthermia

• Registration Number: NCT02369939
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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).

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-24
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11
• Primary Completion: 2017-12
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Irradiation	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
control arm	Irradiation	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
Experimental arm	5-Fluorouracil	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
Experimental arm	Hyperthermia	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
control arm	Mitomycin C	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
control arm	5-Fluorouracil	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
Experimental arm	Mitomycin C	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

Primary Outcome Measures

Name	Time	Method
Improvement of complete remission	12 weeks after start of treatment

Secondary Outcome Measures

Name	Time	Method
locoregional relapse-free survival	5 years after start of treatment
Overall relapse-free survival	5 years after start of treatment
Colostomy-free survival	5 years after start of treatment
Overall survival	5 years after start of treatment
Rate of acute and late toxicity	5 years after start of treatment
Response rate	5 years after start of treatment
Quality of life	5 years after start of treatment

Trial Locations

Locations (1)

Universitaetsklinikum Erlangen, Strahlenklinik; 🇩🇪 Erlangen, Germany