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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

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Locally Advanced Rectal Cancer Hyperthermia Hyperthermic Radiochemotherapy Hyperthermic Chemoradiotherapy Deep Regional Hyperthermia Other: Deep regional hyperthermia Radiation: Radiotherapy Drug: Chemotherapy (5-Fluorouracil) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
Study Start Date : August 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Pathological complete response rate [ Time Frame: After surgical resection (4-6 weeks after last radiotherapy fraction) ]

Secondary Outcome Measures :
  1. Locoregional progression free survival [ Time Frame: 3 years ]
  2. Disease free survival [ Time Frame: 3 years ]
  3. Distant metastases free survival [ Time Frame: 3 years ]
  4. Overall survival [ Time Frame: 3 years ]
  5. Number of hyperthermia treatments [ Time Frame: At completion of hyperthermic radiochemotherapy ]
  6. Acute and chronic treatment related toxicity, according to CTC criteria [ Time Frame: 3 years ]
  7. post operative morbidity [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353858


Locations
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Germany
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02353858    
Other Study ID Numbers: HT01
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Keywords provided by University Hospital Tuebingen:
Rectal Cancer
Hyperthermia
Radiochemotherapy
Chemoradiotherapy
Deep regional hyperthermia
pathologic complete response
Regression Grade
Locally advanced rectal cancer
complete response
Additional relevant MeSH terms:
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Fever
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Body Temperature Changes
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs