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

Information source: University of Erlangen-NŁrnberg Medical School
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer

Intervention: Radiotherapy (Radiation); Hyperthermia (Procedure); 5-Fluorouracil (Drug); Capecitabine (Drug); Oxaliplatin (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of Erlangen-NŁrnberg Medical School

Official(s) and/or principal investigator(s):
Oliver Ott, MD, Principal Investigator, Affiliation: Strahlenklinik, Universitätsklinikum Erlangen

Overall contact:
Oliver Ott, MD, Phone: ++49(0)9131-85, Ext: 33968, Email: st-studiensekretatiat@uk-erlangen.de

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.

Clinical Details

Official title: Multi-institutional Phase I/II Study: Neoadjuvant Chemoradiation With 5-FU (or Capecitabine) and Oxaliplatin Combined With Deep Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Feasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT])

Number of hyperthermia applications by patient

Secondary outcome:

Local progression-free survival

Distant metastasis-free survival

Overall survival

Response rate

Rate of R0-resections

Rate of acute and late toxicity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ‚Č• 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 (‚ȧ 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

Locations and Contacts

Oliver Ott, MD, Phone: ++49(0)9131-85, Ext: 33968, Email: st-studiensekretatiat@uk-erlangen.de

Klinik Bad Trissl, Innere Medizin, Bad Trissl 83080, Germany; Recruiting
Bernhard Weber, MD, Principal Investigator
Friedemann Peschke, MD, Sub-Investigator

University Hospital, Duesseldorf 40225, Germany; Recruiting
Christiane Matuschek, MD, Sub-Investigator

Universitätsklinikum Erlangen, Strahlenklinik, Erlangen 91054, Germany; Recruiting
Oliver Ott, MD, Principal Investigator
Rainer Fietkau, MD, Sub-Investigator

LMU M√ľnchen, Campus Gro√ühadern, Medizinische Klinik III, Hyperthermie, M√ľnchen 81377, Germany; Recruiting
Rolf Issels, MD, Principal Investigator
Katharina Lechner, MD, Sub-Investigator

Schlossbergklinik, Oberstaufen 87534, Germany; Recruiting
Thomas Licht, MD, Principal Investigator
Blair Wolfgang, MD, Sub-Investigator

Universit√§tsklinikum T√ľbingen, Radioonkologie, T√ľbingen 72076, Germany; Recruiting
Daniel Zips, MD, Principal Investigator
Johanna Gellermann, MD, Sub-Investigator

Additional Information

Starting date: September 2012
Last updated: May 29, 2015

Page last updated: August 20, 2015

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