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

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ClinicalTrials.gov Identifier: NCT02369939
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
Estimated 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 : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer Fever

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 Name: any brand is permitted

Drug: 5-Fluorouracil
5-FU w1, w5
Other Name: 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 Name: any brand is permitted

Drug: 5-Fluorouracil
5-FU w1, w5
Other Name: any brand is permitted

Procedure: Hyperthermia
6x deep regional hyperthermia
Other Name: Deep regional hyperthermia




Primary Outcome Measures :
  1. Improvement of complete remission [ Time Frame: 12 weeks after start of treatment ]

Secondary Outcome Measures :
  1. Colostomy-free survival [ Time Frame: 5 years after start of treatment ]
  2. locoregional relapse-free survival [ Time Frame: 5 years after start of treatment ]
  3. Overall relapse-free survival [ Time Frame: 5 years after start of treatment ]
  4. Overall survival [ Time Frame: 5 years after start of treatment ]
  5. Response rate [ Time Frame: 5 years after start of treatment ]
  6. Rate of acute and late toxicity [ Time Frame: 5 years after start of treatment ]
  7. Quality of life [ Time Frame: 5 years after start of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369939


Contacts
Contact: Rainer Fietkau, Prof. Dr. ++49(0)9131-85 ext 33968 st-studiensekretatiat@uk-erlangen.de

Locations
Germany
Universitaetsklinikum Erlangen, Strahlenklinik Recruiting
Erlangen, Germany, 91054
Contact: Rainer Fietkau, Prof. Dr.    ++49(0)9131-85 ext 33968    st-studiensekretariat@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Director: Rainer Fietkau, Prof. Dr. Universitätsklinikum Erlangen, Strahlenklinik

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02369939     History of Changes
Other Study ID Numbers: HYCAN
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by University of Erlangen-Nürnberg Medical School:
anal carcinoma
hyperthermia
radiotherapy
chemotherapy
radiochemotherapy

Additional relevant MeSH terms:
Anus Diseases
Carcinoma
Fever
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Signs and Symptoms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Mitomycins
Mitomycin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic