Back to resultsEffects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy (HYCAN)
Primary Purpose
Anal Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Irradiation
Mitomycin C
5-Fluorouracil
Hyperthermia
Sponsored by
About this trial
This is an interventional treatment trial for Anal Carcinoma focused on measuring anal carcinoma, hyperthermia, radiotherapy, chemotherapy, radiochemotherapy
Eligibility 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
Sites / Locations
- Universitaetsklinikum Erlangen, StrahlenklinikRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control arm
Experimental arm
Arm 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
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
Outcomes
Primary Outcome Measures
Improvement of complete remission
Secondary Outcome Measures
Colostomy-free survival
locoregional relapse-free survival
Overall relapse-free survival
Overall survival
Response rate
Rate of acute and late toxicity
Quality of life
Full Information
NCT ID
NCT02369939
First Posted
January 7, 2015
Last Updated
August 9, 2017
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT02369939
Brief Title
Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
Acronym
HYCAN
Official Title
Randomized Trial to Evaluate Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Carcinoma
Keywords
anal carcinoma, hyperthermia, radiotherapy, chemotherapy, radiochemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control arm
Arm Type
Active Comparator
Arm 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
Arm Title
Experimental arm
Arm Type
Experimental
Arm 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
Intervention Type
Radiation
Intervention Name(s)
Irradiation
Intervention Description
Radiotherapy 55,8 Gy - 59,4 Gy
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Other Intervention Name(s)
any brand is permitted
Intervention Description
MMC w1, w5
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Other Intervention Name(s)
any brand is permitted
Intervention Description
5-FU w1, w5
Intervention Type
Procedure
Intervention Name(s)
Hyperthermia
Other Intervention Name(s)
Deep regional hyperthermia
Intervention Description
6x deep regional hyperthermia
Primary Outcome Measure Information:
Title
Improvement of complete remission
Time Frame
12 weeks after start of treatment
Secondary Outcome Measure Information:
Title
Colostomy-free survival
Time Frame
5 years after start of treatment
Title
locoregional relapse-free survival
Time Frame
5 years after start of treatment
Title
Overall relapse-free survival
Time Frame
5 years after start of treatment
Title
Overall survival
Time Frame
5 years after start of treatment
Title
Response rate
Time Frame
5 years after start of treatment
Title
Rate of acute and late toxicity
Time Frame
5 years after start of treatment
Title
Quality of life
Time Frame
5 years after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Fietkau, Prof. Dr.
Phone
++49(0)9131-85
Ext
33968
Email
st-studiensekretatiat@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Fietkau, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Erlangen, Strahlenklinik
Official's Role
Study Director
Facility Information:
Facility Name
Universitaetsklinikum Erlangen, Strahlenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rainer Fietkau, Prof. Dr.
Phone
++49(0)9131-85
Ext
33968
Email
st-studiensekretariat@uk-erlangen.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
30390114
Citation
Ott OJ, Schmidt M, Semrau S, Strnad V, Matzel KE, Schneider I, Raptis D, Uter W, Grutzmann R, Fietkau R. Chemoradiotherapy with and without deep regional hyperthermia for squamous cell carcinoma of the anus. Strahlenther Onkol. 2019 Jul;195(7):607-614. doi: 10.1007/s00066-018-1396-x. Epub 2018 Nov 2.
Results Reference
derived
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Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
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