Rectal CancerPhase 2HT01NCT02353858
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
A Phase 2 study testing Deep regional hyperthermia, Radiotherapy and Chemotherapy (5-Fluorouracil) in people with Rectal Cancer and Locally Advanced Rectal Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Locally Advanced Rectal Cancer, Hyperthermia
- What is being tested?
- Deep regional hyperthermia, Radiotherapy and Chemotherapy (5-Fluorouracil)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Dec 2017
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge)
- International Union Against Cancer stages II or III
- ECOG PS 0/2
- Informed consent
Who cannot join
- Congestive heart failure (NYHA III/IV)
- History of myocardial infarction within the last 6 months.
- AV Block III
- Total hip replacement or major metal pelvic implants
- Cardiac pacemaker
- Contraindications for radiochemotherapy
Show all 13Show fewer
- Contraindications for surgical tumor resection
- Previous pelvic radiotherapy or chemotherapy
- Active chronic inflammatory bowel disease
- Collagenosis
- Congenital diseases with increased radiosensitivity
- Pregnancy or breastfeeding
- Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.
- Conditions
- Rectal Cancer, Locally Advanced Rectal Cancer, Hyperthermia, Hyperthermic Radiochemotherapy, Hyperthermic Chemoradiotherapy, Deep Regional Hyperthermia
- Being tested
- Deep regional hyperthermia, Radiotherapy, Chemotherapy (5-Fluorouracil)
- Keywords
- Rectal Cancer, Hyperthermia, Radiochemotherapy, Chemoradiotherapy, Deep regional hyperthermia, pathologic complete response, Regression Grade, Locally advanced rectal cancer, complete response
- Medical subject headings
- Rectal Neoplasms, Hyperthermia, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep regional hyperthermiaOther
Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.
RadiotherapyRadiation
Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.
Chemotherapy (5-Fluorouracil)Drug
5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.
| Study group | Role | What they receive |
|---|---|---|
| RtChx + Hyperthermia | Experimental | Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week Receives: Other: Deep regional hyperthermia; Radiation: Radiotherapy; Drug: Chemotherapy (5-Fluorouracil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Measured: After surgical resection (4-6 weeks after last radiotherapy fraction)
Secondary outcomes (7)
Locoregional progression free survival
Measured: 3 years
Disease free survival
Measured: 3 years
Distant metastases free survival
Measured: 3 years
Overall survival
Measured: 3 years
Number of hyperthermia treatments
Measured: At completion of hyperthermic radiochemotherapy
Acute and chronic treatment related toxicity, according to CTC criteria
Measured: 3 years
post operative morbidity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startAug 2012
- Primary completionDec 2017
- Study completionDec 2017
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 Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353858
- Sponsor's protocol ID
- HT01
- Acronym
- HT01
- Status last verified
- Feb 2018
- First submitted
- 2 Dec 2014
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gani C, Lamprecht U, Ziegler A, Moll M, Gellermann J, Heinrich V, Wenz S, Fend F, Konigsrainer A, Bitzer M, Zips D. Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial. Radiother Oncol. 2021 Jun;159:155-160. doi: 10.1016/j.radonc.2021.03.011. Epub 2021 Mar 17.
PubMed 33741467
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT02353858
- Acronym / sponsor ID
- HT01 / HT01
- Conditions
- Rectal Cancer, Locally Advanced Rectal Cancer, Hyperthermia, Hyperthermic Radiochemotherapy, Hyperthermic Chemoradiotherapy, Deep Regional Hyperthermia
- Keywords
- Rectal Cancer, Hyperthermia, Radiochemotherapy, Chemoradiotherapy, Deep regional hyperthermia, pathologic complete response, Regression Grade, Locally advanced rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 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.
The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RtChx + Hyperthermia | Experimental | Other: Deep regional hyperthermia, Radiation: Radiotherapy, Drug: Chemotherapy (5-Fluorouracil)Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge)
- International Union Against Cancer stages II or III
- ECOG PS 0/2
- Informed consent
Key exclusion criteria (13 listed)
- Congestive heart failure (NYHA III/IV)
- History of myocardial infarction within the last 6 months.
- AV Block III
- Total hip replacement or major metal pelvic implants
- Cardiac pacemaker
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 |
|---|---|---|
| Deep regional hyperthermiaDeep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C. | Other | RtChx + Hyperthermia |
| RadiotherapyRadiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy. | Radiation | RtChx + Hyperthermia |
| Chemotherapy (5-Fluorouracil)5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day. | Drug | RtChx + Hyperthermia |
Primary outcome
Pathological complete response rate
Time frame: After surgical resection (4-6 weeks after last radiotherapy fraction)
7 secondary outcomes
Locoregional progression free survival
Time frame: 3 years
Disease free survival
Time frame: 3 years
Distant metastases free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Number of hyperthermia treatments
Time frame: At completion of hyperthermic radiochemotherapy
Acute and chronic treatment related toxicity, according to CTC criteria
Time frame: 3 years
post operative morbidity
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Derived from this study: PubMed 33741467Gani C, Lamprecht U, Ziegler A, Moll M, Gellermann J, Heinrich V, Wenz S, Fend F, Konigsrainer A, Bitzer M, Zips D. Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial. Radiother Oncol. 2021 Jun;159:155-160. doi: 10.1016/j.radonc.2021.03.011. Epub 2021 Mar 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deep regional hyperthermia, Radiotherapy and Chemotherapy (5-Fluorouracil) in people with Rectal Cancer and Locally Advanced Rectal Cancer, run by University Hospital Tuebingen 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 13 Feb 2018. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: After surgical resection (4-6 weeks after last radiotherapy fraction)). 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 NCT02353858, 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 13 Feb 2018.