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Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin) Followed by Capecitabine (Xeloda) Plus Radiotherapy (RTx)


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin) Followed by Capecitabine (Xeloda) Plus Radiotherapy (RTx)


Induction chemotherapy combined with Radio chemotherapy:

Therapy start: within 28 days after bioptical diagnosis capecitabine 1000 mg/m2 bid during
14 days (d1-d14) , oxaliplatin 130 mg/m2 and bevacizumab 7.5 mg/kg body weight d1;
repetition day 22 and 43 (3 cycles)

Combined Radiochemotherapy after 1 week of concluded 3rd cycle of induction chemotherapy:

Radiotherapy: 5 x 5 days 1.8 Gy; cumulative dose 45 Gy Chemotherapy: capecitabine 825mg/m²
bid, on each radiation day during the first 4 weeks of RCTx

Surgery according to TME-criteria (total mesorectal excision) in compliance of an
interruption of min. 14 days after RCTx


Inclusion Criteria:



- Age 18-80 years

- Histologic confirmation of rectal adenocarcinoma stage cT3 (≤ 5mm to the mesorectal
fascia)/cT4( primary curative intention)NxM0

- No former chemotherapy, no former radiotherapy of the pelvic, no former tumour
resection of a rectal carcinoma

- General condition WHO grade 0-2

- Adequate bone marrow reserve ( leucocytes ≥3 000/μl, thrombocytes ≥100 000/μl)

- Adequate renal function (creatinine ≤ 1,5 mg/dl, creatinine clearance > 50ml/min
(Cockcroft and Gault formula))

- Adequate liver function (bilirubin ≤1,5x ULN, GOT and GPT ≤3,5xULN)

- Exclusion of pregnancy for women with childbearing potential (negative pregnancy test
urine or serum)

- Female patients with childbearing potential and male patients that are not surgically
sterile must be practicing a medically acceptable contraceptive regimen while on
study treatment until 3 months after the end of the study (e.g. oral contraceptives,
condom, intrauterine device)

- Life expectancy of at least 3 months

- INR and aPTT ≤ 1,5 x LLN

- Provision of signed informed consents before registration

Exclusion Criteria:

- Rectal carcinoma stage cT3 (> 5mm from the mesorectal fascia) all stages
- Other malignant tumours within the last 5 years except cervical carcinoma in situ and
basal cell carcinoma of the skin

- General contraindication or known hypersensitivity against Bevacizumab, Capecitabine
and Oxaliplatin

- Not malignant diseases for which treatment with radiotherapy, resection of the rectum
and treatment with chemotherapy (Bevacizumab, Capecitabine) is contraindicated:
uncontrolled hypertension (systolic > 150 mmHG and/or diastolic > 100 mmHG) or
clinically significant (e.g. active) cardiovascular diseases: CVA (cardiovascular
accident)/ apoplectic insult (≤ 6 months prior to registration), myocardial
infarction (≤ 6 months prior to registration), unstable angina pectoris,
CHF(congestive heart failure) with NYHA (New York heart Association) Grade II or
higher, cardiac arrhythmia requiring therapy, hepatic diseases, significant
neurologic or psychiatric disorders

- Florid, serious infection at registration

- Peripheral neuropathy (NCI CTCAE v 4.0 ≥ grade 1)

- Juridically limited contractual capability, indication of neurological or psychiatric
disease which constrains upon investigators opinion the patients capability to adhere
to the study routines

- Major surgical procedure within 28 days prior start of the study, open wounds

- Significant traumatic injury, bone fracture, unhealed wounds

- Patients with spinal cord compression or metastases in the central nervous system

- Indication of bleeding diathesis or coagulopathy

- Intake of anticoagulant or thrombolytic agents and/or Aspirin > 325 mg/d within 10
days prior to registration

- Current or recent (within 10 days prior to treatment start) therapy with full dosed
anticoagulants. Preventive therapy is allowed.

- Previous thromboembolic or haemorrhagic events within 6 months prior to registration

- Previous abdominal fistulas, gastro-intestinal perforation or intrabdominal abscesses
within 6 months prior to registration

- Treatment with another investigational drug within 28 days prior to registration

- Patients with malabsorption syndrome or difficulties in swallowing

- Indication of poor compliance of the patient

- Pregnant or breast-feeding women

- Proteinuria: Dipstick <2+. If the Dipstick is ≥2+ protein has to be estimated in the
24 hours urine. The value should not be higher then 1g/24 hours.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

termination of therapy

Outcome Description:

before surgery (after conclusion of therapy phase)

Outcome Time Frame:

up to 17 weeks

Safety Issue:

Yes

Principal Investigator

Dietmar Öfner, MD, Head

Investigator Role:

Study Chair

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group

Authority:

Austria: Agency for Health and Food Safety

Study ID:

ABCSG R05

NCT ID:

NCT01434147

Start Date:

October 2011

Completion Date:

February 2014

Related Keywords:

  • Rectal Cancer
  • locally advanced rectal cancer
  • preoperative induction chemotherapy chemoradiotherapy
  • Rectal Neoplasms

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