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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HyRec

Radiotherapy, Hyperthermia, 5-Fluorouracil (may be replaced by Capecitabine), Capecitabine (may be replaced by 5-Fluorouracil), Oxaliplatin

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

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

Hyperthermia

Intervention Type PROCEDURE

10 sessions, therapeutic time 60 min

5-Fluorouracil

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

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

Oxaliplatin

Intervention Type DRUG

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

Interventions

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Radiotherapy

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

Intervention Type RADIATION

Hyperthermia

10 sessions, therapeutic time 60 min

Intervention Type PROCEDURE

5-Fluorouracil

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

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Oxaliplatin

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

Intervention Type DRUG

Other Intervention Names

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all brands of 5-Fluorouracil are allowed all brands of Capecitabine are allowed all brands of oxaliplatin are allowed

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Histologically confirmed, locally advanced or recurrent (any recurrence of tumor within the lesser pelvis; resectable or non-resectable) adenocarcinoma of the rectum (UICC stage IIB-IV); distant oligo-metastases may be present.
* ECOG-performance status \< 2
* Sufficient bone marrow function:
* WBC \> 3,5 x 10\^9/l
* Neutrophil granulocytes \> 1,5 x 10\^9/l
* Platelets \> 100 x 10\^9/l
* Hemoglobin \> 10 g/dl
* Sufficient liver function: Bilirubin \< 2,0 mg%, SGOT, SGPT, alkaline phosphatase, gGT less than 3 times upper limit of normal
* Serum creatinine \< 1,5 mg%, glomerular filtration rate (or comparable test) \> 50 ml/min
* Signed study-specific consent form prior to therapy
* Fertile patients must use effective contraception during and for 6 months after study treatment
* Considered fit for oxaliplatin and 5-FU-containing combination chemotherapy

Exclusion Criteria

* Pelvic radiotherapy during the last 12 months
* Pregnant or lactating/nursing women
* Drug addiction
* On-treatment participation on other trials
* Active intractable or uncontrollable infection
* Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except rectal cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
* Chronic diarrhea (\> NCI CTC-Grad 1)
* Chronic inflammatory disease of the intestine
* Collagen vascular disease
* The presence of congenital diseases with increased radiation sensitivity, for example teleangiectatic ataxia, or similar
* Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
* Myocardial infarction within the past 12 months
* Congestive heart failure
* Complete bundle branch block
* New York Heart Association (NYHA) class III or IV heart disease
* Known allergic reactions on study medication
* Cardiac pacemaker
* Disease that would preclude chemoradiation or deep regional hyperthermia
* Any metal implants (with exception of non-clustered marker clips)
* Psychological, familial, sociological, or geographical condition that would preclude study compliance
* Patients deemed technically unsatisfactory for deep regional hyperthermia
* Cardiac symptoms (\> NCI CTCAE Grade 1) due to pretreatment with fluoropyrimidines
* Neurological symptoms (\> NCI CTCAE Grade 1) due to pretreatment with oxaliplatin
* Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Oral anticoagulation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No