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

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Radiotherapy

Hyperthermia

5-Fluorouracil

Capecitabine

Oxaliplatin

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, recurrent rectal cancer, hyperthermia, radiation, chemoradiation, 5-FU, capecitabine, oxaliplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik Bad Trissl, Innere MedizinRecruiting
University HospitalRecruiting
Universitätsklinikum Erlangen, StrahlenklinikRecruiting
LMU München, Campus Großhadern, Medizinische Klinik III, HyperthermieRecruiting
SchlossbergklinikRecruiting
Universitätsklinikum Tübingen, RadioonkologieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HyRec

Arm Description

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

Outcomes

Primary Outcome Measures

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

Number of hyperthermia applications by patient

Secondary Outcome Measures

Local progression-free survival

Distant metastasis-free survival

Overall survival

Response rate

Rate of R0-resections

Rate of acute and late toxicity

Full Information

NCT ID

NCT01716949

First Posted

October 5, 2012

Last Updated

August 9, 2017

Sponsor

University of Erlangen-Nürnberg Medical School

1. Study Identification

Unique Protocol Identification Number

NCT01716949

Brief Title

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

Acronym

HyRec

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 Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

rectal cancer, recurrent rectal cancer, hyperthermia, radiation, chemoradiation, 5-FU, capecitabine, oxaliplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HyRec

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Hyperthermia

Intervention Description

10 sessions, therapeutic time 60 min

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil

Other Intervention Name(s)

all brands of 5-Fluorouracil are allowed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

all brands of Capecitabine are allowed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

all brands of oxaliplatin are allowed

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Title

Number of hyperthermia applications by patient

Time Frame

Duration of therapy (approximately 5 to 6 weeks)

Secondary Outcome Measure Information:

Title

Local progression-free survival

Time Frame

Participants will be followed for up to 5 years after the end of therapy (Follow up period)

Title

Distant metastasis-free survival

Time Frame

Participants will be followed for up to 5 years after the end of therapy (Follow up period)

Title

Overall survival

Time Frame

Participants will be followed for up to 5 years after the end of therapy (Follow up period)

Title

Response rate

Time Frame

Participants will be followed for up to 5 years after the end of therapy (Follow up period)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oliver Ott, MD

Phone

++49(0)9131-85

Ext

33968

st-studiensekretatiat@uk-erlangen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Sebastian Lettmaier, MD

Phone

++49(0)9131-85

Ext

33968

st-studiensekretariat@uk-erlangen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Ott, MD

Organizational Affiliation

Strahlenklinik, Universitätsklinikum Erlangen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik Bad Trissl, Innere Medizin

City

Bad Trissl

ZIP/Postal Code

83080

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernhard Weber, MD

First Name & Middle Initial & Last Name & Degree

Friedemann Peschke, MD

Facility Name

University Hospital

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christiane Matuschek, MD

Facility Name

Universitätsklinikum Erlangen, Strahlenklinik

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver Ott, MD

First Name & Middle Initial & Last Name & Degree

Rainer Fietkau, MD

Facility Name

LMU München, Campus Großhadern, Medizinische Klinik III, Hyperthermie

City

München

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rolf Issels, MD

First Name & Middle Initial & Last Name & Degree

Katharina Lechner, MD

Facility Name

Schlossbergklinik

City

Oberstaufen

ZIP/Postal Code

87534

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Licht, MD

First Name & Middle Initial & Last Name & Degree

Blair Wolfgang, MD

Facility Name

Universitätsklinikum Tübingen, Radioonkologie

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Zips, MD

First Name & Middle Initial & Last Name & Degree

Johanna Gellermann, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33805731

Citation

Ott OJ, Gani C, Lindner LH, Schmidt M, Lamprecht U, Abdel-Rahman S, Hinke A, Weissmann T, Hartmann A, Issels RD, Zips D, Belka C, Grutzmann R, Fietkau R. Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer. Cancers (Basel). 2021 Mar 13;13(6):1279. doi: 10.3390/cancers13061279.

Results Reference

derived

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

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