Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number:2007-000456-13 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab & capecitabine & radiotheraphy | Experimental | Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece) | Surgery date |
| Measure | Description | Time Frame |
|---|---|---|
| Overall clinical response | Surgery date | |
| To determine the downstaging caused by treatment | Surgery date | |
| relapse free survival |
Not provided
Inclusion Criteria:
The patient has given written informed consent prior to any study related procedure
Male and female aged 18 to 75 years
ECOG performance status 0 or 1
Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge
Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
Disease evaluable by imaging techniques
No tumour haemorrhage in the week prior to start of study treatment
External derivation in symptomatic occlusive tumours
Not prior cancer treatment
Adequate bone marrow, hepatic and renal function, defined as:
Less than 10% weight loss
Exclusion Criteria:
Rectal cancer no amenable to resection
Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
Pregnant or breast-feeding women
Women oh childbearing potential unless effective methods of contraception are used
No prior or concurrent significant medical conditions, including any of the following:
Major trauma within the past 28 days
Serious nonhealing wound, ulcer, or bone fracture
Evidence of bleeding diathesis or coagulopathy
No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
No known dihydropyrimidine dehydrogenase deficiency
Major surgery in the 4 weeks prior to the start of study treatment
No concurrent chronic, daily treatment with aspirin (> 325 mg/day)
More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes
No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation
No other medical history or condition that, in the opinion of the investigator, would preclude study participation
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ramon Salazar, Phd | Institut Català d'Oncologia | Principal Investigator |
| Margarita Garcia, MD | Institut Català d'Oncologia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Català d'Oncologia-L'Hospitalet | L'Hospitalet Del Llobregat | Barcelona | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25886275 | Result | Garcia M, Martinez-Villacampa M, Santos C, Navarro V, Teule A, Losa F, Pisa A, Cambray M, Soler G, Lema L, Kreisler E, Figueras A, Juan XS, Vinals F, Biondo S, Salazar R. Phase II study of preoperative bevacizumab, capecitabine and radiotherapy for resectable locally-advanced rectal cancer. BMC Cancer. 2015 Feb 26;15:59. doi: 10.1186/s12885-015-1052-0. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| capecitabine (Xeloda) | Drug | Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period |
|
| Rectal Radiotherapy | Radiation | Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. |
|
| Time of radiological evidence of relapse. |
| Quantify the local control grade: R0 resections in surgery | Surgery date |
| Local relapse and distant relapse rates | Relapse date |
| To determine the security profile of this neoadjuvant treatment (radio- chemotherapy) | From date of register to surgery date |
| Surgery complication rate | During surgery admission. |
| To determine the angiogenic profile changes in tumour. | 15 days, 6 weeks and 4 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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 |