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Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer

NCT01716949 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-08-11

No results posted yet for this study

Summary

This trial examines the feasibility, effectiveness and safety of a combination of radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively improved tumor regression allowing less aggressive surgery in primary locally advanced rectal cancer and a higher rate of curative resections in heavily pretreated locally recurrent rectal cancers.

Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates, and toxicity. It is planned to include a total number of 59 patients over a period of 2.5 years.

Conditions

Interventions

RADIATION

Radiotherapy

45 up to 50.4 Gy; daily dose 1,8 Gy, 5 days per weeks

PROCEDURE

Hyperthermia

10 sessions, therapeutic time 60 min

DRUG

5-Fluorouracil

250 mg/m\^2/d as continuous i.v. infusion on d1-14, 22-35 (may be preplaced by Capecitabine)

DRUG

Capecitabine

1650 mg/m\^2/d oral intake d1-14, 22-35 (may be replaced by 5-Fluorouracil)

DRUG

Oxaliplatin

50 mg/m\^2/d as 2-hour bolus infusion on d2, 9, 23, 30

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Oliver Ott, MD · Strahlenklinik, Universitätsklinikum Erlangen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2022-06-30
Completion
2023-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716949 on ClinicalTrials.gov