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Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer (HT01)

Primary Purpose

Rectal Cancer, Locally Advanced Rectal Cancer, Hyperthermia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Deep regional hyperthermia
Radiotherapy
Chemotherapy (5-Fluorouracil)
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Hyperthermia, Radiochemotherapy, Chemoradiotherapy, Deep regional hyperthermia, pathologic complete response, Regression Grade, Locally advanced rectal cancer, complete response

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University Hospital Tübingen, Department of Radiation Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RtChx + Hyperthermia

Arm Description

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

Outcomes

Primary Outcome Measures

Pathological complete response rate

Secondary Outcome Measures

Locoregional progression free survival
Disease free survival
Distant metastases free survival
Overall survival
Number of hyperthermia treatments
Acute and chronic treatment related toxicity, according to CTC criteria
post operative morbidity

Full Information

First Posted
December 2, 2014
Last Updated
February 12, 2018
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02353858
Brief Title
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Acronym
HT01
Official Title
Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, complete response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RtChx + Hyperthermia
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Deep regional hyperthermia
Intervention Description
Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy (5-Fluorouracil)
Intervention Description
5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.
Primary Outcome Measure Information:
Title
Pathological complete response rate
Time Frame
After surgical resection (4-6 weeks after last radiotherapy fraction)
Secondary Outcome Measure Information:
Title
Locoregional progression free survival
Time Frame
3 years
Title
Disease free survival
Time Frame
3 years
Title
Distant metastases free survival
Time Frame
3 years
Title
Overall survival
Time Frame
3 years
Title
Number of hyperthermia treatments
Time Frame
At completion of hyperthermic radiochemotherapy
Title
Acute and chronic treatment related toxicity, according to CTC criteria
Time Frame
3 years
Title
post operative morbidity
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
University Hospital Tübingen, Department of Radiation Oncology
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33741467
Citation
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.
Results Reference
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Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

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