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

Anal Carcinoma Clinical Trial

— HYCAN  

Official title:

Randomized Trial to Evaluate Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02369939
• Other study ID #: HYCAN
• Status: Recruiting
• Phase: Phase 3
• First received: January 7, 2015
• Last updated: August 9, 2017
• Start date: December 2014
• Est. completion date: April 2021

Study information

• Verified date: August 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Rainer Fietkau, Prof. Dr.
• Phone: ++49(0)9131-85
• Email: st-studiensekretatiat[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: April 2021
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Carcinoma
• Anus Neoplasms
• Carcinoma
• Fever

Intervention

Radiation:
• Irradiation
Radiotherapy 55,8 Gy - 59,4 Gy

Drug:
• Mitomycin C
MMC w1, w5
• 5-Fluorouracil
5-FU w1, w5

Procedure:
• Hyperthermia
6x deep regional hyperthermia

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Erlangen, Strahlenklinik	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of complete remission		12 weeks after start of treatment
Secondary	Colostomy-free survival		5 years after start of treatment
Secondary	locoregional relapse-free survival		5 years after start of treatment
Secondary	Overall relapse-free survival		5 years after start of treatment
Secondary	Overall survival		5 years after start of treatment
Secondary	Response rate		5 years after start of treatment
Secondary	Rate of acute and late toxicity		5 years after start of treatment
Secondary	Quality of life		5 years after start of treatment