Clinical trial NCT02369939: Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
Official title: Randomized Trial to Evaluate Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anal Carcinoma
Keywords: anal carcinoma
hyperthermia
radiotherapy
chemotherapy
radiochemotherapy
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Improvement of complete remission
timeFrame: 12 weeks after start of treatment
Secondary outcomes:
measure: Colostomy-free survival
timeFrame: 5 years after start of treatment
measure: locoregional relapse-free survival
timeFrame: 5 years after start of treatment
measure: Overall relapse-free survival
timeFrame: 5 years after start of treatment
measure: Overall survival
timeFrame: 5 years after start of treatment
measure: Response rate
timeFrame: 5 years after start of treatment
measure: Rate of acute and late toxicity
timeFrame: 5 years after start of treatment
measure: Quality of life
timeFrame: 5 years after start of treatment
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen, Strahlenklinik
Study officials:
affiliation: Universitätsklinikum Erlangen, Strahlenklinik
name: Rainer Fietkau, Prof. Dr.
role: STUDY_DIRECTOR
References:
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.