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

NCT01716949 | Unknown Phase 1

• 1 other identifier: ESHO201107/001
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 6

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.

Conditions

Rectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  Participants will be followed for the duration of therapy and for 6 weeks after the last study treatment dose (approximately 11 to 12 weeks)

• Number of hyperthermia applications by patient

  Duration of therapy (approximately 5 to 6 weeks)

Secondary Outcomes (6)

• Local progression-free survival

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

• Distant metastasis-free survival

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

• Overall survival

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

• Response rate

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

• Rate of R0-resections

  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)

Study Arms (1)

HyRec

EXPERIMENTAL

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

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

Interventions

Radiotherapy RADIATION

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

HyRec

Hyperthermia PROCEDURE

10 sessions, therapeutic time 60 min

HyRec

5-Fluorouracil DRUG

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

Also known as: all brands of 5-Fluorouracil are allowed

HyRec

Capecitabine DRUG

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

Also known as: all brands of Capecitabine are allowed

HyRec

Oxaliplatin DRUG

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

Also known as: all brands of oxaliplatin are allowed

HyRec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (6)

Klinik Bad Trissl, Innere Medizin

Bad Trissl, 83080, Germany

RECRUITING

University Hospital

Düsseldorf, 40225, Germany

RECRUITING

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, 91054, Germany

RECRUITING

LMU München, Campus Großhadern, Medizinische Klinik III, Hyperthermie

München, 81377, Germany

RECRUITING

Schlossbergklinik

Oberstaufen, 87534, Germany

RECRUITING

Universitätsklinikum Tübingen, Radioonkologie

Tübingen, 72076, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 33805731 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Hyperthermia

Interventions

Radiotherapy; Diathermy; Fluorouracil; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Hyperthermia, Induced; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Oliver Ott, MD

  Strahlenklinik, Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Ott, MD

CONTACT

++49(0)9131-85; st-studiensekretatiat@uk-erlangen.de

Sebastian Lettmaier, MD

CONTACT

++49(0)9131-85; st-studiensekretariat@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 30, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

DE (6)