Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007177-23 | EudraCT Number | ||
| MO19051 | Other Grant/Funding Number | UZ Leuven with support from Roche and Sanofi |
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Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.
To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).
See Synopsis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXE (ARM 1) | Active Comparator | Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. |
|
| AX (ARM 2) | Active Comparator | Bevacizumab and Capecitabine concurrently with radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | Administered on days 15,22,29,36 en 43; 50 mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. | Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Histopathologic R0 and Negative CRM Resection | Histopathologic R0 resection rate was defined as margins histologically negative for tumour involvement after resection. The circumferential resection margin (CRM) is considered to be involved if microscopic tumour is present <1mm from or at the inked circumferential or radial resection margin. Data on quality of mesorectal excision were expected but not collected consistently. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Van Cutsem, Prof. Dr. | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwziekenhuis | Aalst | 9300 | Belgium | |||
| ZNA Middelheim |
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Target population was represented by patients with locally advanced rectal cancer (tumour beyond mesorectal fascia (T4) or tumour ≤ 2 mm from mesorectal fascia or T3 tumour < 5 cm from anal verge by MRI), histologically confirmed. Pts were screened as per incl and excl criteria per protocol. Screening failures were not recorded in the eCRF.
Eighty-four patients were included. First patient enrolled: 22-Jun-2009. Last patient enrolled: 29-Sep-2013. Participating sites: UZ Leuven, Erasme Hospital Bruxelles, Cliniques Universitaires St-Luc Bruxelles, AZ St. Lucas Brugge, AZ Groeninge Kortrijk, CHU Sart-Tilman Liege, OLVZ Aalst, H. Hart Ziekenhuis Roeselare, Cl. Saint Elisabeth Namur
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AXE (ARM 1) | Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-treatment (Baseline) |
|
Not provided
Not provided
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| Bevacizumab | Drug | Administered on days 1,15,29 and 43 ; 5mg/kg |
|
|
| Capecitabine | Drug | 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy |
|
|
| radiotherapy | Radiation | Total dose 45Gy |
|
| 4 months |
| Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery. | Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100. | 4 months |
| Clinical Response Rate | Baseline tumour measurements were performed within 4 weeks prior to treatment start (RECIST). The same methods of assessment (CT and/or MRI) were used for each measurable lesion at baseline and during follow-up.
| 3 months |
| Types and Numbers of Adverse Events - General Overview | Adverse events graded as per NCI CTCAE (US National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0. All Serious Adverse Events occurrences are reported and counts are summarized here; all Adverse Events (all grades) related and not related to study treatment are reported and summarized here; all severe laboratory events (hematology and biochemistry Gr 3 and higher) are reported and summarized here; all severe postoperative complications (Gr 3 and higher) occurred within the first month post surgery are reported and summarized here. See section Adverse events for details. | continuous up to 1 year |
| Recurrence Rates and Disease Free Survival | Counts and proportions of patients experiencing recurrence of disease (local and distant). | up to 5 years |
| Death Rates and Overall Survival | Counts and proportions of patients deceased (post-study). | up to 5 years |
| Antwerp |
| ZNA Middelheim |
| Belgium |
| AZ St- Lucas | Bruges | 8310 | Belgium |
| Erasme Hospital | Brussels | 1070 | Belgium |
| Cliniques Universitaires St Luc | Brussels | 1200 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| C.H.U. Sart-Tilman | Liège | 4000 | Belgium |
| Clinique Sainte Elisabeth | Namur | 5000 | Belgium |
| H. Hartziekenhuis | Roeselare | 8800 | Belgium |
| AX (ARM 2) |
Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy |
| COMPLETED |
|
| NOT COMPLETED |
|
| Study Treatment |
|
|
| Post-surgery (<30 Days) |
|
|
| Follow-up |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AXE (ARM 1) | Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy |
| BG001 | AX (ARM 2) | Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| ECOG PS (Performance Status) | ECOG PS = 0 Fully active, able to carry on all pre-disease performance without restriction; ECOG PS = 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work | Count of Participants | Participants |
| |||||||||||||||||
| Distance from tumour to anal verge | Distance from tumour to anal verge measured during colonoscopy (in cm). | Count of Participants | Participants |
| |||||||||||||||||
| Distance to CRM | Distance to CRM measured by MRI | Count of Participants | Participants |
| |||||||||||||||||
| Tumour stage | Tumour staging was done using clinical, radiological and pathological assessments on rectal biopsies. Tumors (T) were graded using the colon and rectum cancer staging (TNM, American Joint Committee on Cancer 7th edition) where T2 tumors are less severe then T3 tumors and T4 tumors respectively. | Count of Participants | Participants |
| |||||||||||||||||
| Nodal stage | Nodal staging was done using clinical, radiological and pathological assessments where applicable. Lymph node involvement (N) was graded using the colon and rectum cancer staging (TNM, American Joint Committee on Cancer 7th edition) where N0 is no regional lymph node involved and N1 is less severe then N2 involvement. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. | Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100. | Patients who had undertaken surgery and had pathology materials available for central review (centrally reviewed subset) | Posted | Number | 95% Confidence Interval | percentage of cases | 4 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Histopathologic R0 and Negative CRM Resection | Histopathologic R0 resection rate was defined as margins histologically negative for tumour involvement after resection. The circumferential resection margin (CRM) is considered to be involved if microscopic tumour is present <1mm from or at the inked circumferential or radial resection margin. Data on quality of mesorectal excision were expected but not collected consistently. | Patient in Arm 2 that discontinued chemoradiotherapy due to major toxicity and had surgery off protocol is counted here as well | Posted | Count of Participants | Participants | 4 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery. | Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100. | Centrally reviewed subset | Posted | Count of Participants | Participants | 4 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response Rate | Baseline tumour measurements were performed within 4 weeks prior to treatment start (RECIST). The same methods of assessment (CT and/or MRI) were used for each measurable lesion at baseline and during follow-up.
| Intent to treat, all registered patients | Posted | Count of Participants | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Types and Numbers of Adverse Events - General Overview | Adverse events graded as per NCI CTCAE (US National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0. All Serious Adverse Events occurrences are reported and counts are summarized here; all Adverse Events (all grades) related and not related to study treatment are reported and summarized here; all severe laboratory events (hematology and biochemistry Gr 3 and higher) are reported and summarized here; all severe postoperative complications (Gr 3 and higher) occurred within the first month post surgery are reported and summarized here. See section Adverse events for details. | Intent to treat | Posted | Number | counts of events | continuous up to 1 year |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence Rates and Disease Free Survival | Counts and proportions of patients experiencing recurrence of disease (local and distant). | Intent to treat (one patient lost to follow-up) | Posted | Count of Participants | Participants | up to 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Death Rates and Overall Survival | Counts and proportions of patients deceased (post-study). | Intent to treat in follow up (one patient in Arm 1 lost to follow up). | Posted | Count of Participants | Participants | up to 5 years |
|
|
From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable
All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AXE (ARM 1) | Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy | 0 | 43 | 21 | 43 | 18 | 43 |
| EG001 | AX (ARM 2) | Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy | 1 | 41 | 12 | 41 | 15 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung embolism | Vascular disorders | NCI CTC AE V3 | Systematic Assessment | Lung embolism Gr 5 - Postoperative |
|
| Neuropathy motor | Nervous system disorders | NCI CTC AE V3 | Systematic Assessment | Neuropathy, motor (cranial, palate, pharynx) Gr 3 (swallowing problems) - During chemoradiotherapy |
|
| Seizure | Nervous system disorders | NCI CTC AE V3 | Systematic Assessment | Seizure Gr 2 in a patient with epileptic background - During chemoradiotherapy |
|
| Fever | General disorders | NCI CTC AE V3 | Systematic Assessment | Fever Gr 1 - During chemoradiotherapy |
|
| Depression | Psychiatric disorders | NCI CTC AE V3 | Systematic Assessment | Depression Gr 3 - During chemoradiotherapy |
|
| Rectal haemorrhage | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Rectal haemorrhage Gr 2 following rectal biopsy. During chemoradiotherapy |
|
| Diarrhea | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Diarrhea Gr 3 - During chemoradiotherapy |
|
| Fistula | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Fistula Gr 3 - Postoperative |
|
| Leak | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Anastomotic leak Gr 3; 2 in arm 1 and 3 in arm 2 - all events also SAE - Postoperative |
|
| Obstruction | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Obstruction GI Gr 2 and Gr 3; both arm 1 Postoperative |
|
| Presacral hematoma | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Presacral hematoma Gr 2 - Postoperative |
|
| Febrile neutropenia | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Febrile neutropenia Gr 3 - During chemoradiotherapy |
|
| Septic shock | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Catheter related infection Gr 4 - During chemoradiotherapy |
|
| Urinary tract infection | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Urinary tract infection Gr 2 (1 in each arm) and 1 Urinary tract infection Gr 3 in arm 1 - During chemoradiotherapy |
|
| Catheter site infection | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Catheter site infection Gr 3 with positive hemocultures - Postoperative |
|
| Wound infection | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | 5 peri-anal wound infections Gr 3 (4 in arm 1; 1 in arm 2) ; 1 wound with evisceration Gr 4 in arm 1 ; 1 Gr 5 wound infection in a patient with tumor break during surgery in arm 2 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep venous thrombosis | Vascular disorders | NCI CTC AE V3 | Systematic Assessment | DVT Gr 3 - Postoperative |
|
| Embolism | Vascular disorders | NCI CTC AE V3 | Systematic Assessment | Embolism Gr 4 and embolism Gr 5 - both in arm 2 |
|
| Fatigue | General disorders | NCI CTC AE V3 | Systematic Assessment | Fatigue Gr 3 (2 pts in arm 1 and 1 pt in arm 2 - also an SAE for this pt) - during chemoradiotherapy |
|
| Depression | Psychiatric disorders | NCI CTC AE V3 | Systematic Assessment | Depression Gr 3 - also an SAE - during chemoradiotherapy |
|
| Sweating | General disorders | NCI CTC AE V3 | Systematic Assessment | Sweating Gr 3 - Postoperative |
|
| Hypertension b | Cardiac disorders | NCI CTC AE V3 | Systematic Assessment | Hypertension Gr 3 - baseline |
|
| Hypertension | Cardiac disorders | NCI CTC AE V3 | Systematic Assessment | Hypertension Gr 3 in 2 pts in arm 2 - during chemoradiotherapy |
|
| Cardiopulmonary arrest | Cardiac disorders | NCI CTC AE V3 | Systematic Assessment | Cardiopulmonary arrest Gr 5 - FU post EOT visit |
|
| Pain pumonary/respiratory | Respiratory, thoracic and mediastinal disorders | NCI CTC AE V3 | Systematic Assessment | Sore throat Gr 3 and laryngeal pain Gr 3 in one patient in arm 2 - during chemoradiotherapy |
|
| Platelet count decreased | Blood and lymphatic system disorders | NCI CTC AE V3 | Systematic Assessment | Platelet count decreased Gr 3 - during chemoradiotherapy |
|
| Haemorrhage | Blood and lymphatic system disorders | NCI CTC AE V3 | Systematic Assessment | Hemorrhage with surgery Gr 3 |
|
| Dissiminated Intravascular Coagulation | Blood and lymphatic system disorders | NCI CTC AE V3 | Systematic Assessment | Disseminated Intravascular Coagulation Gr 3 - during chemoradiotherapy |
|
| Hematoma postoperative | Blood and lymphatic system disorders | NCI CTC AE V3 | Systematic Assessment | Hematoma Gr 3 in 1 pt in arm 2 (also SAE) - postoperative |
|
| Hematoma | Blood and lymphatic system disorders | NCI CTC AE V3 | Systematic Assessment | Hematoma Gr 3 (also an SAE) - FU post EOT visit |
|
| Neuropathy sensory | Nervous system disorders | NCI CTC AE V3 | Systematic Assessment | Neuropathy sensory Gr 3 - during chemoradiotherapy |
|
| Syncope | Nervous system disorders | NCI CTC AE V3 | Systematic Assessment | Syncope Gr 3 - during chemoradiotherapy |
|
| Neuropathy - cranial | Nervous system disorders | NCI CTC AE V3 | Systematic Assessment | Neuropathy -cranial Gr 3 (also an SAE) - FU post EOT visit |
|
| Meniere's disease | Ear and labyrinth disorders | NCI CTC AE V3 | Systematic Assessment | Pt with baseline Meniere's disease Gr 3 (since 1999) - Baseline |
|
| Anorexia | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Anorexia Gr 3 - during chemoradiotherapy |
|
| Diarrhea | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Diarrhea Gr 3 in 4 pts in arm 1 (three episodes were an SAE) - during chemoradiotherapy |
|
| Anal pain | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Pain gastro-intestinal - anal pain Gr 3 |
|
| Leak Gi | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Leak GI Gr 3 - postoperative |
|
| Obstruction Gi | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Obstruction GI Gr 3 in 2 pts in arm 1 (for 1 also an SAE) and in 1 pt in arm 2 (also an SAE) - postoperative |
|
| Pain GI | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Stomach pain Gr 3 and pain due to leak Gr 3 - postoperative |
|
| Discharge from the anus | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Purulent discharge from the anus Gr - - postoperative |
|
| Ascites | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Ascites Gr 5 - FU post EOT visit |
|
| Dysphagia | Gastrointestinal disorders | NCI CTC AE V3 | Systematic Assessment | Dysphagia Gr 3 - FU post EOT visit |
|
| Leak GU | Renal and urinary disorders | NCI CTC AE V3 | Systematic Assessment | Leak GU Gr 5 - postoperative |
|
| Dermatitis | Skin and subcutaneous tissue disorders | NCI CTC AE V3 | Systematic Assessment | Dermatitis associated with radiotherapy Gr 3 |
|
| Pain musculoskeletal | Musculoskeletal and connective tissue disorders | NCI CTC AE V3 | Systematic Assessment | Pain musculoskeletal Gr 3 - Postoperative |
|
| Rash | Skin and subcutaneous tissue disorders | NCI CTC AE V3 | Systematic Assessment | Rash Gr 3 - during chemoradiotherapy |
|
| Pain muskuloskeletal Gr 3 | Musculoskeletal and connective tissue disorders | NCI CTC AE V3 | Systematic Assessment | Pain muskuloskeletal Gr 3 - postoperative |
|
| Hypocalcemia | Metabolism and nutrition disorders | NCI CTC AE V3 | Systematic Assessment | Hypocalcemia Gr 3 - during chemoradiotherapy |
|
| Hypokalemia | Musculoskeletal and connective tissue disorders | NCI CTC AE V3 | Systematic Assessment | Hypokalemia Gr 3 - during chemoradiotherapy |
|
| Hyponatremia | Metabolism and nutrition disorders | NCI CTC AE V3 | Systematic Assessment | Hyponatremia Gr 3 - during chemoradiotherapy |
|
| Febrile neutropenia | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Febrile neutropenia Gr 3 (also an SAE) - during chemoradiotherapy |
|
| Catheter site infection | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Catheter site infection Gr 3 (also an SAE) - during chemoradiotherapy |
|
| Sepsis | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Sepsis Gr 3 and septic shock Gr 4 - during chemoradiotherapy |
|
| Wound infection | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | 5 peri-anal wound infections Gr 3 ; 1 wound infection with evisceration Gr 4 ; 1 Gr 5 wound infection in a patient with tumor break during surgery |
|
| Peritonitis | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Peritonitis Gr 5 (tumor break during surgery) - part of SAE |
|
| Infection due to leak of anastomosis | Infections and infestations | NCI CTC AE V3 | Systematic Assessment | Infection due to leak of anastomosis Gr 3 (part of an SAE) - follow-up |
|
The study was not powered to allow for formal statistical comparisons between arms
The Sponsor is an academic institution and not the drug market authorization holder. Participating PIs were selected from other academic institutions. Participating PIs cannot publish full or partial study results before final publication by Sponsor, but they will be nominated as co-authors based on patient accrual at each participating site. Own results can be published afterwards by participant PIs, with the agreement of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Eric Van Cutsem | UZ Leuven | +32 16 34 42 18 | Eric.VanCutsem@uzleuven.be |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
Not provided
Not provided
| Complete response, no surgery |
|
| >=65 years |
|
| Male |
|
| ECOG PS=1 |
|
| >=5cm |
|
| NA |
|
| <2mm |
|
| >=2mm |
|
| NA |
|
| T3 (tumor invades into pericolorectal tissues) |
|
| T4 (tumor invades through peritoneum/other organs) |
|
| N1 (metastasis in 1-3 regional lymp nodes) |
|
| N2 (metastasis in 4 or more regional lymph nodes) |
|
| Nx (regional nodes cannot be assessed) |
|
| Little tumour regression (Dworak TRG=0-1-2) % |
|
| Units | Counts |
|---|
| Participants |
|
|
| AX (ARM 2) |
Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy |
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Bevacizumab and Capecitabine concurrently with radiotherapy
Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg
Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
Radiotherapy: Total dose 45Gy
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| Units | Counts |
|---|---|
| Participants |
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