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

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ClinicalTrials.gov Identifier: NCT02353858
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE December 2, 2014
First Posted Date  ICMJE February 3, 2015
Last Update Posted Date February 13, 2018
Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
Pathological complete response rate [ Time Frame: After surgical resection (4-6 weeks after last radiotherapy fraction) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Official Title  ICMJE Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rectal Cancer
  • Locally Advanced Rectal Cancer
  • Hyperthermia
  • Hyperthermic Radiochemotherapy
  • Hyperthermic Chemoradiotherapy
  • Deep Regional Hyperthermia
Intervention  ICMJE
  • Other: Deep regional hyperthermia
    Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.
  • Radiation: Radiotherapy
    Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.
  • Drug: Chemotherapy (5-Fluorouracil)
    5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.
Study Arms  ICMJE Experimental: RtChx + Hyperthermia
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
Interventions:
  • Other: Deep regional hyperthermia
  • Radiation: Radiotherapy
  • Drug: Chemotherapy (5-Fluorouracil)
Publications * Gani C, Lamprecht U, Ziegler A, Moll M, Gellermann J, Heinrich V, Wenz S, Fend F, Königsrainer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2015)
78
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353858
Other Study ID Numbers  ICMJE HT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Tuebingen
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP