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

NCT02369939 | Unknown Phase 3

• 1 other identifier: HYCAN
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Carcinoma

Keywords

anal carcinoma; hyperthermia; radiotherapy; chemotherapy; radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• Improvement of complete remission

  12 weeks after start of treatment

Secondary Outcomes (7)

• Colostomy-free survival

  5 years after start of treatment

• locoregional relapse-free survival

  5 years after start of treatment

• Overall relapse-free survival

  5 years after start of treatment

• Overall survival

  5 years after start of treatment

• Response rate

  5 years after start of treatment

Study Arms (2)

control arm

ACTIVE COMPARATOR

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; Drug: Mitomycin C; Drug: 5-Fluorouracil

Experimental arm

EXPERIMENTAL

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; Drug: Mitomycin C; Drug: 5-Fluorouracil; Procedure: Hyperthermia

Interventions

Irradiation RADIATION

Radiotherapy 55,8 Gy - 59,4 Gy

Experimental arm; control arm

Mitomycin C DRUG

MMC w1, w5

Also known as: any brand is permitted

Experimental arm; control arm

5-Fluorouracil DRUG

5-FU w1, w5

Also known as: any brand is permitted

Experimental arm; control arm

Hyperthermia PROCEDURE

6x deep regional hyperthermia

Also known as: Deep regional hyperthermia

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universitaetsklinikum Erlangen, Strahlenklinik

Erlangen, 91054, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 30390114 DERIVED

MeSH Terms

Conditions

Anus Neoplasms; Hyperthermia

Interventions

Radiation; Mitomycin; Fluorouracil; Diathermy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Phenomena; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Uracil; Pyrimidinones; Pyrimidines; Hyperthermia, Induced; Therapeutics

Study Officials

• Rainer Fietkau, Prof. Dr.

  Universitätsklinikum Erlangen, Strahlenklinik

  STUDY DIRECTOR

Central Study Contacts

Rainer Fietkau, Prof. Dr.

CONTACT

++49(0)9131-85; st-studiensekretatiat@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: February 24, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2021
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

DE (1)