NCT02353858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

5.3 years

First QC Date

December 2, 2014

Last Update Submit

February 12, 2018

Conditions

Rectal CancerLocally Advanced Rectal CancerHyperthermiaHyperthermic RadiochemotherapyHyperthermic ChemoradiotherapyDeep Regional Hyperthermia

Keywords

Rectal CancerHyperthermiaRadiochemotherapyChemoradiotherapyDeep regional hyperthermiapathologic complete responseRegression GradeLocally advanced rectal cancercomplete response

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response rate

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

Secondary Outcomes (7)

  • Locoregional progression free survival

    3 years

  • Disease free survival

    3 years

  • Distant metastases free survival

    3 years

  • Overall survival

    3 years

  • Number of hyperthermia treatments

    At completion of hyperthermic radiochemotherapy

  • +2 more secondary outcomes

Study Arms (1)

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

Other: Deep regional hyperthermiaRadiation: RadiotherapyDrug: Chemotherapy (5-Fluorouracil)

Interventions

Deep regional hyperthermiaOTHER

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

RtChx + Hyperthermia
RadiotherapyRADIATION

Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.

RtChx + Hyperthermia
Chemotherapy (5-Fluorouracil)DRUG

5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.

RtChx + Hyperthermia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33741467DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsHyperthermiaPathologic Complete Response

Interventions

RadiotherapyDrug TherapyFluorouracil

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and InjuriesDisease ProgressionDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

TherapeuticsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

February 3, 2015

Study Start

August 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

DE(1)