Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer (HyRec)
This study is currently recruiting participants.
Verified April 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01716949
First received: October 5, 2012
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Radiation: Radiotherapy Procedure: Hyperthermia Drug: 5-Fluorouracil Drug: Capecitabine Drug: Oxaliplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- Feasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT]) [ Time Frame: Participants will be followed for the duration of therapy and for 6 weeks after the last study treatment dose (approximately 11 to 12 weeks) ] [ Designated as safety issue: Yes ]
- Number of hyperthermia applications by patient [ Time Frame: Duration of therapy (approximately 5 to 6 weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Local progression-free survival [ Time Frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period) ] [ Designated as safety issue: No ]
- Distant metastasis-free survival [ Time Frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period) ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period) ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period) ] [ Designated as safety issue: No ]
- Rate of R0-resections [ Time Frame: Only of participants who are considered as resectable receive surgery in curative intention 4-6 weeks after completion of chemoradiation (results app. after 10 to 12 weeks after start of therapy) ] [ Designated as safety issue: No ]
- Rate of acute and late toxicity [ Time Frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 59 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | April 2020 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HyRec
Radiotherapy, Hyperthermia, 5-Fluorouracil (may be replaced by Capecitabine), Capecitabine (may be replaced by 5-Fluorouracil), Oxaliplatin
|
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)
Other Name: all brands of 5-Fluorouracil are allowed
Drug: Capecitabine
1650 mg/m^2/d oral intake d1-14, 22-35 (may be replaced by 5-Fluorouracil)
Other Name: all brands of Capecitabine are allowed
Drug: Oxaliplatin
50 mg/m^2/d as 2-hour bolus infusion on d2, 9, 23, 30
Other Name: all brands of oxaliplatin are allowed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716949
Contacts
| Contact: Oliver Ott, MD | ++49(0)9131-85 ext 33968 | st-studiensekretatiat@uk-erlangen.de |
| Contact: Sebastian Lettmaier, MD | ++49(0)9131-85 ext 33968 | st-studiensekretariat@uk-erlangen.de |
Locations
| Germany | |
| Klinik Bad Trissl, Innere Medizin | Recruiting |
| Bad Trissl, Germany, 83080 | |
| Principal Investigator: Bernhard Weber, MD | |
| Sub-Investigator: Friedemann Peschke, MD | |
| Universitätsklinikum Erlangen, Strahlenklinik | Recruiting |
| Erlangen, Germany, 91054 | |
| Principal Investigator: Oliver Ott, MD | |
| Sub-Investigator: Rainer Fietkau, MD | |
| LMU München, Campus Großhadern, Medizinische Klinik III, Hyperthermie | Recruiting |
| München, Germany, 81377 | |
| Principal Investigator: Rolf Issels, MD | |
| Sub-Investigator: Katharina Lechner, MD | |
| Schlossbergklinik | Recruiting |
| Oberstaufen, Germany, 87534 | |
| Principal Investigator: Thomas Licht, MD | |
| Sub-Investigator: Blair Wolfgang, MD | |
| Universitätsklinikum Tübingen, Radioonkologie | Recruiting |
| Tübingen, Germany, 72076 | |
| Principal Investigator: Daniel Zips, MD | |
| Sub-Investigator: Johanna Gellermann, MD | |
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
| Principal Investigator: | Oliver Ott, MD | Strahlenklinik, Universitätsklinikum Erlangen |
More Information
No publications provided
| Responsible Party: | University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT01716949 History of Changes |
| Other Study ID Numbers: | ESHO201107/001 |
| Study First Received: | October 5, 2012 |
| Last Updated: | April 2, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Erlangen-Nürnberg Medical School:
|
rectal cancer recurrent rectal cancer hyperthermia radiation |
chemoradiation 5-FU capecitabine oxaliplatin |
Additional relevant MeSH terms:
|
Rectal Neoplasms Fever Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Body Temperature Changes |
Signs and Symptoms Fluorouracil Capecitabine Oxaliplatin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013