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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT02369939

Collaborator

(none)

118

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anal Carcinoma	Radiation: Irradiation Drug: Mitomycin C Drug: 5-Fluorouracil Procedure: Hyperthermia	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control arm 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	Radiation: Irradiation Radiotherapy 55,8 Gy - 59,4 Gy Drug: Mitomycin C MMC w1, w5 Other Names: any brand is permitted Drug: 5-Fluorouracil 5-FU w1, w5 Other Names: any brand is permitted
Experimental: Experimental arm 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	Radiation: Irradiation Radiotherapy 55,8 Gy - 59,4 Gy Drug: Mitomycin C MMC w1, w5 Other Names: any brand is permitted Drug: 5-Fluorouracil 5-FU w1, w5 Other Names: any brand is permitted Procedure: Hyperthermia 6x deep regional hyperthermia Other Names: Deep regional hyperthermia

Arm

Intervention/Treatment

Active Comparator: control arm

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

Radiation: Irradiation

Radiotherapy 55,8 Gy - 59,4 Gy

Drug: Mitomycin C

MMC w1, w5

Other Names:

any brand is permitted

Drug: 5-Fluorouracil

5-FU w1, w5

Other Names:

any brand is permitted

Experimental: Experimental arm

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

Radiation: Irradiation

Radiotherapy 55,8 Gy - 59,4 Gy

Drug: Mitomycin C

MMC w1, w5

Other Names:

any brand is permitted

Drug: 5-Fluorouracil

5-FU w1, w5

Other Names:

any brand is permitted

Procedure: Hyperthermia

6x deep regional hyperthermia

Other Names:

Deep regional hyperthermia

Outcome Measures

Primary Outcome Measures

Improvement of complete remission [12 weeks after start of treatment]

Secondary Outcome Measures

Colostomy-free survival [5 years after start of treatment]
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]
Response rate [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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