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

August 9, 2017 updated by: University of Erlangen-Nürnberg Medical School

Randomized Trial to Evaluate Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • any brand is permitted
Drug: 5-Fluorouracil
5-FU w1, w5
Other Names:
  • 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 Names:
  • any brand is permitted
Drug: 5-Fluorouracil
5-FU w1, w5
Other Names:
  • any brand is permitted
Procedure: Hyperthermia
6x deep regional hyperthermia
Other Names:
  • Deep regional hyperthermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of complete remission
Time Frame: 12 weeks after start of treatment
12 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Colostomy-free survival
Time Frame: 5 years after start of treatment
5 years after start of treatment
locoregional relapse-free survival
Time Frame: 5 years after start of treatment
5 years after start of treatment
Overall relapse-free survival
Time Frame: 5 years after start of treatment
5 years after start of treatment
Overall survival
Time Frame: 5 years after start of treatment
5 years after start of treatment
Response rate
Time Frame: 5 years after start of treatment
5 years after start of treatment
Rate of acute and late toxicity
Time Frame: 5 years after start of treatment
5 years after start of treatment
Quality of life
Time Frame: 5 years after start of treatment
5 years after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Study Director: Rainer Fietkau, Prof. Dr., Universitätsklinikum Erlangen, Strahlenklinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYCAN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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