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Completed

NCT Number: NCT02353858

Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

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.

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Key information

Conditions

Rectal Cancer Body Temperature Changes Colorectal Neoplasms Deep Regional Hyperthermia Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Gastrointestinal Diseases Gastrointestinal Neoplasms Heat Stress Disorders Hyperthermia Hyperthermic Chemoradiotherapy Hyperthermic Radiochemotherapy Intestinal Diseases Intestinal Neoplasms Locally Advanced Rectal Cancer Neoplasms Neoplasms by Site Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Signs and Symptoms Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep regional hyperthermia

Other

Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.

Radiotherapy

Radiation

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.

Primary outcomes

  1. Pathological complete response rate

    Time frame: After surgical resection (4-6 weeks after last radiotherapy fraction)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial

Acronym: HT01

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2015
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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