Anal CarcinomaPhase 3HYCANNCT02369939
Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
A Phase 3 study testing Irradiation, Mitomycin C and 5-Fluorouracil in people with Anal Carcinoma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Carcinoma
- What is being tested?
- Irradiation, Mitomycin C and 5-Fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitaetsklinikum Erlangen, Strahlenklinik
Erlangen, 91054
Rainer Fietkau, Prof. Dr., ++49(0)9131-85 ext. 33968, st-studiensekretariat@uk-erlangen.de
About this study
Official title: 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.
Read the 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).
- Conditions
- Anal Carcinoma
- Being tested
- Irradiation, Mitomycin C, 5-Fluorouracil, Hyperthermia
- Keywords
- anal carcinoma, hyperthermia, radiotherapy, chemotherapy, radiochemotherapy
- Medical subject headings
- Anus Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrradiationRadiation
Radiotherapy 55,8 Gy - 59,4 Gy
Mitomycin CDrug
Also called any brand is permitted
MMC w1, w5
5-FluorouracilDrug
Also called any brand is permitted
5-FU w1, w5
HyperthermiaProcedure or surgery
Also called Deep regional hyperthermia
6x deep regional hyperthermia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Irradiation; Drug: Mitomycin C; Drug: 5-Fluorouracil; Procedure: Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of complete remission
Measured: 12 weeks after start of treatment
Secondary outcomes (7)
Colostomy-free survival
Measured: 5 years after start of treatment
locoregional relapse-free survival
Measured: 5 years after start of treatment
Overall relapse-free survival
Measured: 5 years after start of treatment
Overall survival
Measured: 5 years after start of treatment
Response rate
Measured: 5 years after start of treatment
Rate of acute and late toxicity
Measured: 5 years after start of treatment
Quality of life
Measured: 5 years after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Fietkau, Prof. Dr., Study director, Universitätsklinikum Erlangen, Strahlenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369939
- Sponsor's protocol ID
- HYCAN
- Acronym
- HYCAN
- Status last verified
- Aug 2017
- First submitted
- 7 Jan 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30390114
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
- ClinicalTrials.gov ID
- NCT02369939
- Acronym / sponsor ID
- HYCAN / HYCAN
- Conditions
- Anal Carcinoma
- Keywords
- anal carcinoma, hyperthermia, radiotherapy, chemotherapy, radiochemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | Active comparator | Radiation: Irradiation, Drug: Mitomycin C, Drug: 5-FluorouracilIrradiation 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 |
| Experimental arm | Experimental | Radiation: Irradiation, Drug: Mitomycin C, Drug: 5-Fluorouracil, Procedure: HyperthermiaIrradiation 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrradiationRadiotherapy 55,8 Gy - 59,4 Gy | Radiation | Experimental arm, control arm |
| Mitomycin CAlso: any brand is permittedMMC w1, w5 | Drug | Experimental arm, control arm |
| 5-FluorouracilAlso: any brand is permitted5-FU w1, w5 | Drug | Experimental arm, control arm |
| HyperthermiaAlso: Deep regional hyperthermia6x deep regional hyperthermia | Procedure or surgery | Experimental arm |
Primary outcome
Improvement of complete remission
Time frame: 12 weeks after start of treatment
7 secondary outcomes
Colostomy-free survival
Time frame: 5 years after start of treatment
locoregional relapse-free survival
Time frame: 5 years after start of treatment
Overall relapse-free survival
Time frame: 5 years after start of treatment
Overall survival
Time frame: 5 years after start of treatment
Response rate
Time frame: 5 years after start of treatment
Rate of acute and late toxicity
Time frame: 5 years after start of treatment
Quality of life
Time frame: 5 years after start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Derived from this study: PubMed 30390114Ott 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.
Related trials for Anal Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Fietkau, Prof. Dr. study director
Universitätsklinikum Erlangen, Strahlenklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irradiation, Mitomycin C and 5-Fluorouracil in people with Anal Carcinoma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainer Fietkau, Prof. Dr. (++49(0)9131-85 ext. 33968, st-studiensekretatiat@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of complete remission (time frame: 12 weeks after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.