Rectal CancerPhase 2NCT01434147
Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy
A Phase 2 study testing preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine in people with Rectal Cancer, run by Austrian Breast & Colorectal Cancer Study Group at 7 sites in Austria.
Trial summary
Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesAustria
- Study dates
- Oct 2011to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Show all 12Show fewer
- 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
Who cannot join
- Rectal carcinoma stage cT3 (> 5mm from the mesorectal fascia) all stages <cT3, M1
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Austria7 sites
State Hospital Feldkirch, Radiotherapy
Feldkirch, Vorarlberg, 6807
Medical University Graz, Oncology
Graz, Styria, 8036
Medical University Innsbruck, Internal Medicine
Innsbruck, Tyrol, 6020
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, 9330
Paracelsus Medical University Salzburg - Oncology
Salzburg, State of Salzburg, 5020
Medical University of Vienna, General Hospital
Vienna, State of Vienna, 1090
Klinikum Wels-Grieskirchen
Wels, Upper Austria, 4600
About this study
Official title: 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 II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
Read the detailed description
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
- Conditions
- Rectal Cancer
- Being tested
- preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine
- Keywords
- locally advanced rectal cancer, preoperative induction chemotherapy chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabineDrug
Also called Xeloda (capecitabine), Avastin (bevacizumab), Oxaliplatin
Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
| Study group | Role | What they receive |
|---|---|---|
| induction chemotherapy + radiochemotherapy | Experimental | preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine induction chemotherapy: starts within 28 days after bioptical diagnosis. All patients are administered with capecitabine (Xeloda®) 1000 mg/m2 bid during 14 days (d1-d14), oxaliplatin 130 mg/m2 and bevacizumab (Avastin®) 7.5 mg/kg body weight on day 1; repetition days 22 and 43 (3 cycles) Combined radiochemotherapy: starts at the earliest one week after concluded third cycle of induction chemotherapy. Radiotherapy takes place on 5 x 5 days (dose: 1.8 Gy; cumulative dose: 45 Gy). For chemotherapy patients are administered with capecitabine (Xeloda®) 825mg/m² bid, on each radiation day during the first 4 weeks of radiochemotherapy. Receives: Drug: preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
termination of therapy
before surgery (after conclusion of therapy phase)
Measured: up to 17 weeks
occurence of toxicity
until timepoint of discharge of patient
Measured: up to 18-19 weeks
Secondary outcomes (2)
collection of response rate
T- and N-downstaging, pathological complete remission: measurement at the timepoint of surgery
Measured: up to week 18
post-surgery morbidity
according to Accordion; measurement at the timepoint of discharge of patient
Measured: after 18-19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Dietmar Öfner, MD, Head, Study chair, Austrian Breast & Colorectal Cancer Study GroupAlexander de Vries, MD, Head, Study chair, Austrian Breast & Colorectal Cancer Study GroupWolfgang Eisterer, MD, Study chair, Austrian Breast & Colorectal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434147
- Sponsor's protocol ID
- ABCSG R05
- Other IDs
- 2010-024354-11
- Status last verified
- Mar 2014
- First submitted
- 13 Sep 2011
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
NIH consensus conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA. 1990 Sep 19;264(11):1444-50. No abstract available.
PubMed 2202842Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):23-30. doi: 10.1200/JCO.2004.09.046. Epub 2003 Dec 9.
PubMed 14665611MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet. 1993 Feb 20;341(8843):457-60. doi: 10.1016/0140-6736(93)90207-w.
PubMed 8094488Budach et al. Stellenwert der Radio- und Radiochemotherapie beim Rektumkarzinom. Onkologe 1998;4:40-48
Kockerling F, Reymond MA, Altendorf-Hofmann A, Dworak O, Hohenberger W. Influence of surgery on metachronous distant metastases and survival in rectal cancer. J Clin Oncol. 1998 Jan;16(1):324-9. doi: 10.1200/JCO.1998.16.1.324.
PubMed 9440760Valentini V, Aristei C, Glimelius B, Minsky BD, Beets-Tan R, Borras JM, Haustermans K, Maingon P, Overgaard J, Pahlman L, Quirke P, Schmoll HJ, Sebag-Montefiore D, Taylor I, Van Cutsem E, Van de Velde C, Cellini N, Latini P; Scientific Committee. Multidisciplinary Rectal Cancer Management: 2nd European Rectal Cancer Consensus Conference (EURECA-CC2). Radiother Oncol. 2009 Aug;92(2):148-63. doi: 10.1016/j.radonc.2009.06.027.
PubMed 19595467Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.
PubMed 14657227Arkenau HT, Arnold D, Cassidy J, Diaz-Rubio E, Douillard JY, Hochster H, Martoni A, Grothey A, Hinke A, Schmiegel W, Schmoll HJ, Porschen R. Efficacy of oxaliplatin plus capecitabine or infusional fluorouracil/leucovorin in patients with metastatic colorectal cancer: a pooled analysis of randomized trials. J Clin Oncol. 2008 Dec 20;26(36):5910-7. doi: 10.1200/JCO.2008.16.7759. Epub 2008 Nov 17.
PubMed 19018087Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.
PubMed 15175435Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. doi: 10.1200/JCO.2005.00.232. Epub 2005 May 2.
PubMed 15867200Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, Schwartz MA, Benson AB 3rd; Eastern Cooperative Oncology Group Study E3200. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007 Apr 20;25(12):1539-44. doi: 10.1200/JCO.2006.09.6305.
PubMed 17442997Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930.
PubMed 18421054Tebutt et al. International randomized phase III study of Capecitabine (Cap), bevacizumab (Bev), and mitomycin C (MMC) in first-line metastatic colorectal cancer (mCRC): Final results of the AGITG MAX trial. Proc ASCO 2010, #3538
Willett CG, Boucher Y, di Tomaso E, Duda DG, Munn LL, Tong RT, Chung DC, Sahani DV, Kalva SP, Kozin SV, Mino M, Cohen KS, Scadden DT, Hartford AC, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Chen HX, Shellito PC, Lauwers GY, Jain RK. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat Med. 2004 Feb;10(2):145-7. doi: 10.1038/nm988. Epub 2004 Jan 25.
PubMed 14745444Willett CG, Boucher Y, Duda DG, di Tomaso E, Munn LL, Tong RT, Kozin SV, Petit L, Jain RK, Chung DC, Sahani DV, Kalva SP, Cohen KS, Scadden DT, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Shellito PC, Mino-Kenudson M, Lauwers GY. Surrogate markers for antiangiogenic therapy and dose-limiting toxicities for bevacizumab with radiation and chemotherapy: continued experience of a phase I trial in rectal cancer patients. J Clin Oncol. 2005 Nov 1;23(31):8136-9. doi: 10.1200/JCO.2005.02.5635. No abstract available.
PubMed 16258121
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01434147
- Acronym / sponsor ID
- ABCSG R05
- Conditions
- Rectal Cancer
- Keywords
- locally advanced rectal cancer, preoperative induction chemotherapy chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| induction chemotherapy + radiochemotherapy | Experimental | Drug: preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabinepreoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine induction chemotherapy: starts within 28 days after bioptical diagnosis. All patients are administered with capecitabine (Xeloda®) 1000 mg/m2 bid during 14 days (d1-d14), oxaliplatin 130 mg/m2 and bevacizumab (Avastin®) 7.5 mg/kg body weight on day 1; repetition days 22 and 43 (3 cycles) Combined radiochemotherapy: starts at the earliest one week after concluded third cycle of induction chemotherapy. Radiotherapy takes place on 5 x 5 days (dose: 1.8 Gy; cumulative dose: 45 Gy). For chemotherapy patients are administered with capecitabine (Xeloda®) 825mg/m² bid, on each radiation day during the first 4 weeks of radiochemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (20 listed)
- Rectal carcinoma stage cT3 (> 5mm from the mesorectal fascia) all stages <cT3, M1
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabineAlso: Xeloda (capecitabine), Avastin (bevacizumab), OxaliplatinTherapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks) | Drug | induction chemotherapy + radiochemotherapy |
Primary outcome
termination of therapy
Time frame: up to 17 weeks
before surgery (after conclusion of therapy phase)
occurence of toxicity
Time frame: up to 18-19 weeks
until timepoint of discharge of patient
2 secondary outcomes
collection of response rate
Time frame: up to week 18
post-surgery morbidity
Time frame: after 18-19 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Background: PubMed 2202842NIH consensus conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA. 1990 Sep 19;264(11):1444-50. No abstract available.
- Background: PubMed 14665611Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):23-30. doi: 10.1200/JCO.2004.09.046. Epub 2003 Dec 9.
- Background: PubMed 8094488MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet. 1993 Feb 20;341(8843):457-60. doi: 10.1016/0140-6736(93)90207-w.
- BackgroundBudach et al. Stellenwert der Radio- und Radiochemotherapie beim Rektumkarzinom. Onkologe 1998;4:40-48
- Background: PubMed 9440760Kockerling F, Reymond MA, Altendorf-Hofmann A, Dworak O, Hohenberger W. Influence of surgery on metachronous distant metastases and survival in rectal cancer. J Clin Oncol. 1998 Jan;16(1):324-9. doi: 10.1200/JCO.1998.16.1.324.
- Background: PubMed 19595467Valentini V, Aristei C, Glimelius B, Minsky BD, Beets-Tan R, Borras JM, Haustermans K, Maingon P, Overgaard J, Pahlman L, Quirke P, Schmoll HJ, Sebag-Montefiore D, Taylor I, Van Cutsem E, Van de Velde C, Cellini N, Latini P; Scientific Committee. Multidisciplinary Rectal Cancer Management: 2nd European Rectal Cancer Consensus Conference (EURECA-CC2). Radiother Oncol. 2009 Aug;92(2):148-63. doi: 10.1016/j.radonc.2009.06.027.
- Background: PubMed 14657227Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.
- Background: PubMed 19018087Arkenau HT, Arnold D, Cassidy J, Diaz-Rubio E, Douillard JY, Hochster H, Martoni A, Grothey A, Hinke A, Schmiegel W, Schmoll HJ, Porschen R. Efficacy of oxaliplatin plus capecitabine or infusional fluorouracil/leucovorin in patients with metastatic colorectal cancer: a pooled analysis of randomized trials. J Clin Oncol. 2008 Dec 20;26(36):5910-7. doi: 10.1200/JCO.2008.16.7759. Epub 2008 Nov 17.
- Background: PubMed 15175435Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.
- Background: PubMed 15867200Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. doi: 10.1200/JCO.2005.00.232. Epub 2005 May 2.
- Background: PubMed 17442997Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, Schwartz MA, Benson AB 3rd; Eastern Cooperative Oncology Group Study E3200. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007 Apr 20;25(12):1539-44. doi: 10.1200/JCO.2006.09.6305.
- Background: PubMed 18421054Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930.
- open studiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dietmar Öfner, MD, Head study chair
Austrian Breast & Colorectal Cancer Study Group
Alexander de Vries, MD, Head study chair
Austrian Breast & Colorectal Cancer Study Group
Wolfgang Eisterer, MD study chair
Austrian Breast & Colorectal Cancer Study Group
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine in people with Rectal Cancer, run by Austrian Breast & Colorectal Cancer Study Group at 7 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
termination of therapy (time frame: up to 17 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01434147, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2014.