AzTrials
AzTrials

Rectal CancerPhase 1/2HyRecNCT01716949

Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer

A Phase 1/2 study testing Radiotherapy, Hyperthermia and 5-Fluorouracil in people with Rectal Cancer, run by University of Erlangen-Nürnberg Medical School at 6 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This trial examines the feasibility, effectiveness and safety of a combination of radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally advanced or locally recurrent rectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Radiotherapy, Hyperthermia and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
6 sitesGermany
Study dates
Sep 2012to Jun 2023
Phase
Phase 1/2
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

  • Age ≥ 18 years
  • Histologically confirmed, locally advanced or recurrent (any recurrence of tumor within the lesser pelvis; resectable or non-resectable) adenocarcinoma of the rectum (UICC stage IIB-IV); distant oligo-metastases may be present.
  • ECOG-performance status < 2
  • Sufficient bone marrow function:
  • WBC > 3,5 x 10^9/l
  • Neutrophil granulocytes > 1,5 x 10^9/l
Show all 13Show fewer
  • Platelets > 100 x 10^9/l
  • Hemoglobin > 10 g/dl
  • Sufficient liver function: Bilirubin < 2,0 mg%, SGOT, SGPT, alkaline phosphatase, gGT less than 3 times upper limit of normal
  • Serum creatinine < 1,5 mg%, glomerular filtration rate (or comparable test) > 50 ml/min
  • Signed study-specific consent form prior to therapy
  • Fertile patients must use effective contraception during and for 6 months after study treatment
  • Considered fit for oxaliplatin and 5-FU-containing combination chemotherapy

Who cannot join

  • Pelvic radiotherapy during the last 12 months
  • Pregnant or lactating/nursing women
  • Drug addiction
  • On-treatment participation on other trials
  • Active intractable or uncontrollable infection
  • Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except rectal cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
Show all 25Show fewer
  • Chronic diarrhea (> NCI CTC-Grad 1)
  • Chronic inflammatory disease of the intestine
  • Collagen vascular disease
  • The presence of congenital diseases with increased radiation sensitivity, for example teleangiectatic ataxia, or similar
  • 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
  • Known allergic reactions on study medication
  • Cardiac pacemaker
  • Disease that would preclude chemoradiation or deep regional hyperthermia
  • Any metal implants (with exception of non-clustered marker clips)
  • Psychological, familial, sociological, or geographical condition that would preclude study compliance
  • Patients deemed technically unsatisfactory for deep regional hyperthermia
  • Cardiac symptoms (> NCI CTCAE Grade 1) due to pretreatment with fluoropyrimidines
  • Neurological symptoms (> NCI CTCAE Grade 1) due to pretreatment with oxaliplatin
  • Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Oral anticoagulation

Trial locations and contacts

6 sites in 1 country.

Oliver Ott, MD contact

++49(0)9131-85 ext. 33968

st-studiensekretatiat@uk-erlangen.de

Sebastian Lettmaier, MD contact

++49(0)9131-85 ext. 33968

st-studiensekretariat@uk-erlangen.de

6 sites in 1 country

Germany6 sites, 6 recruiting

  • Klinik Bad Trissl, Innere Medizin

    Bad Trissl, 83080

    Bernhard Weber, MD

    Friedemann Peschke, MD

    Recruiting

  • University Hospital

    Düsseldorf, 40225

    Christiane Matuschek, MD

    Recruiting

  • Universitätsklinikum Erlangen, Strahlenklinik

    Erlangen, 91054

    Oliver Ott, MD

    Rainer Fietkau, MD

    Recruiting

  • LMU München, Campus Großhadern, Medizinische Klinik III, Hyperthermie

    München, 81377

    Rolf Issels, MD

    Katharina Lechner, MD

    Recruiting

  • Schlossbergklinik

    Oberstaufen, 87534

    Thomas Licht, MD

    Blair Wolfgang, MD

    Recruiting

  • Universitätsklinikum Tübingen, Radioonkologie

    Tübingen, 72076

    Daniel Zips, MD

    Johanna Gellermann, MD

    Recruiting

Other trials in Germany

About this study

Official title: Multi-institutional Phase I/II Study: Neoadjuvant Chemoradiation With 5-FU (or Capecitabine) and Oxaliplatin Combined With Deep Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer

This trial examines the feasibility, effectiveness and safety of a combination of radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively improved tumor regression allowing less aggressive surgery in primary locally advanced rectal cancer and a higher rate of curative resections in heavily pretreated locally recurrent rectal cancers.

Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates, and toxicity. It is planned to include a total number of 59 patients over a period of 2.5 years.

Conditions
Rectal Cancer
Being tested
Radiotherapy, Hyperthermia, 5-Fluorouracil, Capecitabine, Oxaliplatin
Keywords
rectal cancer, recurrent rectal cancer, hyperthermia, radiation, chemoradiation, 5-FU, capecitabine, oxaliplatin
Medical subject headings
Rectal Neoplasms, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    45 up to 50.4 Gy; daily dose 1,8 Gy, 5 days per weeks

  • HyperthermiaProcedure or surgery

    10 sessions, therapeutic time 60 min

  • 5-FluorouracilDrug

    Also called all brands of 5-Fluorouracil are allowed

    250 mg/m^2/d as continuous i.v. infusion on d1-14, 22-35 (may be preplaced by Capecitabine)

  • CapecitabineDrug

    Also called all brands of Capecitabine are allowed

    1650 mg/m^2/d oral intake d1-14, 22-35 (may be replaced by 5-Fluorouracil)

  • OxaliplatinDrug

    Also called all brands of oxaliplatin are allowed

    50 mg/m^2/d as 2-hour bolus infusion on d2, 9, 23, 30

Study groups in NCT01716949
Study groupRoleWhat they receive
HyRecExperimentalRadiotherapy, Hyperthermia, 5-Fluorouracil (may be replaced by Capecitabine), Capecitabine (may be replaced by 5-Fluorouracil), Oxaliplatin
Receives: Radiation: Radiotherapy; Procedure: Hyperthermia; Drug: 5-Fluorouracil; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT])

    Measured: Participants will be followed for the duration of therapy and for 6 weeks after the last study treatment dose (approximately 11 to 12 weeks)

  2. Number of hyperthermia applications by patient

    Measured: Duration of therapy (approximately 5 to 6 weeks)

Secondary outcomes (6)

  1. Local progression-free survival

    Measured: Participants will be followed for up to 5 years after the end of therapy (Follow up period)

  2. Distant metastasis-free survival

    Measured: Participants will be followed for up to 5 years after the end of therapy (Follow up period)

  3. Overall survival

    Measured: Participants will be followed for up to 5 years after the end of therapy (Follow up period)

  4. Response rate

    Measured: Participants will be followed for up to 5 years after the end of therapy (Follow up period)

  5. Rate of R0-resections

    Measured: Only of participants who are considered as resectable receive surgery in curative intention 4-6 weeks after completion of chemoradiation (results app. after 10 to 12 weeks after start of therapy)

  6. Rate of acute and late toxicity

    Measured: Participants will be followed for up to 5 years after the end of therapy (Follow up period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJun 2022 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716949
Sponsor's protocol ID
ESHO201107/001
Acronym
HyRec
Status last verified
Aug 2017
First submitted
5 Oct 2012
Last updated
11 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Ott OJ, Gani C, Lindner LH, Schmidt M, Lamprecht U, Abdel-Rahman S, Hinke A, Weissmann T, Hartmann A, Issels RD, Zips D, Belka C, Grutzmann R, Fietkau R. Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer. Cancers (Basel). 2021 Mar 13;13(6):1279. doi: 10.3390/cancers13061279.

    PubMed 33805731

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radiotherapy, Hyperthermia and 5-Fluorouracil in people with Rectal Cancer, run by University of Erlangen-Nürnberg Medical School at 6 sites 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 13 inclusion and 25 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 6 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Oliver Ott, MD (++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?

Feasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT]) (time frame: Participants will be followed for the duration of therapy and for 6 weeks after the last study treatment dose (approximately 11 to 12 weeks)). The study lists 2 primary outcomes in all. 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 NCT01716949, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in