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 : Unknown
Verified August 2017 by University of Erlangen-Nürnberg Medical School.
Recruitment status was: Recruiting
First Posted : February 24, 2015
Last Update Posted : August 11, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anal Carcinoma | Radiation: Irradiation Drug: Mitomycin C Drug: 5-Fluorouracil Procedure: Hyperthermia | Phase 3 |
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 |
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
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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
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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 |
- Improvement of complete remission [ Time Frame: 12 weeks after start of treatment ]
- Colostomy-free survival [ Time Frame: 5 years after start of treatment ]
- locoregional relapse-free survival [ Time Frame: 5 years after start of treatment ]
- Overall relapse-free survival [ Time Frame: 5 years after start of treatment ]
- Overall survival [ Time Frame: 5 years after start of treatment ]
- Response rate [ Time Frame: 5 years after start of treatment ]
- Rate of acute and late toxicity [ Time Frame: 5 years after start of treatment ]
- Quality of life [ Time Frame: 5 years after start of treatment ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Rainer Fietkau, Prof. Dr. | ++49(0)9131-85 ext 33968 | st-studiensekretatiat@uk-erlangen.de |
Germany | |
Universitaetsklinikum Erlangen, Strahlenklinik | Recruiting |
Erlangen, Germany, 91054 | |
Contact: Rainer Fietkau, Prof. Dr. ++49(0)9131-85 ext 33968 st-studiensekretariat@uk-erlangen.de |
Study Director: | Rainer Fietkau, Prof. Dr. | Universitätsklinikum Erlangen, Strahlenklinik |
Responsible Party: | University of Erlangen-Nürnberg Medical School |
ClinicalTrials.gov Identifier: | NCT02369939 |
Other Study ID Numbers: |
HYCAN |
First Posted: | February 24, 2015 Key Record Dates |
Last Update Posted: | August 11, 2017 |
Last Verified: | August 2017 |
anal carcinoma hyperthermia radiotherapy chemotherapy radiochemotherapy |
Carcinoma Anus Neoplasms Hyperthermia Fever Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Body Temperature Changes Heat Stress Disorders Wounds and Injuries Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Fluorouracil Mitomycins Mitomycin Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors |