Clinical trial · Interventional
Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
Randomized Trial to Evaluate Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
NCT02369939CI-TRIAL-00029040HYCANunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Carcinoma | Anal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Hyperthermia | Procedure | — | UNRESOLVED |
| Irradiation | Radiation | — | UNRESOLVED |
| Mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- 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
- interventionNames
- Radiation: Irradiation
- Drug: Mitomycin C
- Drug: 5-Fluorouracil
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 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
- interventionNames
- Radiation: Irradiation
- Drug: Mitomycin C
- Drug: 5-Fluorouracil
- Procedure: Hyperthermia
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOtt 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