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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2021-04-30

Brief Summary

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Randomized study to investigate the efficacy of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.

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Detailed Description

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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).

Conditions

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Anal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Irradiation

Intervention Type RADIATION

Radiotherapy 55,8 Gy - 59,4 Gy

Mitomycin C

Intervention Type DRUG

MMC w1, w5

5-Fluorouracil

Intervention Type DRUG

5-FU w1, w5

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

Group Type EXPERIMENTAL

Irradiation

Intervention Type RADIATION

Radiotherapy 55,8 Gy - 59,4 Gy

Mitomycin C

Intervention Type DRUG

MMC w1, w5

5-Fluorouracil

Intervention Type DRUG

5-FU w1, w5

Hyperthermia

Intervention Type PROCEDURE

6x deep regional hyperthermia

Interventions

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Irradiation

Radiotherapy 55,8 Gy - 59,4 Gy

Intervention Type RADIATION

Mitomycin C

MMC w1, w5

Intervention Type DRUG

5-Fluorouracil

5-FU w1, w5

Intervention Type DRUG

Hyperthermia

6x deep regional hyperthermia

Intervention Type PROCEDURE

Other Intervention Names

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any brand is permitted any brand is permitted Deep regional hyperthermia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No