Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer

NCT01759238 | Terminated Phase 2 DMC

• 2 other identifiers: OLGA2011-005296-16
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in oligometastatic patients neither being progressive nor resectable after chemotherapy.

Conditions

Colorectal Cancer; Metastases

Keywords

colorectal cancer; metastases; non resectable; chemoradiation

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate

  Progression free survival rate at 12 months after start of induction treatment (PFSR@12)

  12 months

Secondary Outcomes (6)

• Time to progression (TTP) in 2 cohorts

  24 months

• Overall Response Rate

  12 months

• Overall survival (OS)

  36 months

• Quality of life (QoL)

  12 months

• Prognostic and predictive value of PET scan

  at baseline and 2 months after chemoradiation

Study Arms (1)

Chemoradiation

EXPERIMENTAL

Chemoradiation with different radiotherapy regimes (depending on location and size of irradiated lesions; e.g. conventional radiotherapy with a total dose of 35 Gy, delivered in 2.5Gy fractions for 14 days or intensity-modulated and image-guided radiotherapy with a total dose of 40 Gy, delivered in 4.0 Gy fractions for 10 days or 3-8 fractions with 8-15 Gy) combined with bevacizumab (7.5mg/kg day 1) and capecitabine (825mg/m2 bid on day 1-5, 8-12 and 15-19)

Drug: Capecitabine; Drug: Bevacizumab; Radiation: Radiotherapy

Interventions

Capecitabine DRUG

825mg/m2 per os bid

Chemoradiation

Bevacizumab DRUG

7.5 mg/kg

Chemoradiation

Radiotherapy RADIATION

(conventional or intensity-modulated and image-guided radiotherapy)

Chemoradiation

Eligibility Criteria

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

You may qualify if:

• Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer
• Oligometastatic disease, defined as at least one measureable lesion with size \> 1cm (RECIST v1.1) to a maximum of 3 sites and 5 lesions suitable for radiotherapy according to the dose constraints for normal tissue
• Patients being neither progressive nor resectable after 3-6 months of first line chemotherapy (combination chemotherapy, at least chemo-doublet) with bevacizumab
• maximum treatment interruption after induction therapy of 6 weeks
• ECOG performance status ≤ 1
• Life expectancy \> 3 months
• Age ≥ 18 years
• Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L
• INR \< 1.5 within 7 days prior to starting study treatment. aPTT \< 1.5 ULN within 7 days prior to starting study treatment
• adequate liver function as measured by serum transaminases (AST \& ALT) ≤ 5 x ULN and a total bilirubin ≤1.5 x ULN
• adequate renal function: serum creatinine ≤ 1.5 x ULN
• signed, written informed consent
• ability to swallow tablets

You may not qualify if:

• treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
• prior radiotherapy for metastatic lesions (prior radiotherapy for primary tumor allowed if followed by complete resection and no sign for local recurrence at the time of enrolment)
• Pre history or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures
• fertile women (\< 2 years after last menstruation) and women of childbearing potential unwilling or unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel or surgically sterile)
• pregnancy or lactation
• Positive serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women \< 2 years after the onset of menopause. Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded.
• Past or current history (within the last 2 years prior to treatment start) of other malignancies except metastatic colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
• Known DPD-insufficiency
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as \> 4 loose stools per day)
• Serious, non-healing wound, ulcer or bone fracture.
• Evidence of bleeding diathesis or coagulopathy.
• Urine dipstick for proteinuria \>2+. If urine dipstick is 2+, 24-hour urine must demonstrate 1 g of protein in 24 hours for patient to be eligible.
• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first treatment with study medication.
• Clinically significant cardiovascular disease, for example CVA, myocardial infarction (£ 12 months before treatment start), unstable angina pectoris, NYHA Class II CHF, arrhythmia requiring medication, or uncontrolled hypertension.
• Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Capecitabine; Bevacizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Cordula Petersen, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: January 3, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

DE (1)