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| Name | Class |
|---|---|
| Royal Marsden NHS Foundation Trust | OTHER |
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Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.
XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX without Bevacizumab will be administrated for an additional cycle over a 4 week period. Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous Capecitabine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Neoadyuvant chemotherapy with XELOX: Xeloda 1000mg/m2/12h dayly, day one in the afternoon until day 15 in the morning; plus oxaliplatin 130mg/m2 (day 1); and Bevacizumab 7.5 mg/kg (day 1)during 3 cycles (each cycle of 3 weeks). Followed by a selective use of chemoradiotherapy with radiotherapy (50.4Gy, 28 sesions of 1.8Gy during 5 weeks) plus Xeloda 825mg/m2/12h dayly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria | Until the end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Study treatment,which selectively omits neoadjuvant irradiation,can achieve a R0= 90% | At least 3 years for local recurrence and systemic recurrence | |
| Rate of local and systemic recurrence | At least 3 years for local recurrence and systemic recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Fernández Martos, Oncologist | Instituto Valenciano de Oncología (IVO) | Study Chair |
| Carles Pericay, Oncologist | Complejo Sanitario Parc Taulí | Study Director |
| Antonieta Salud, Oncologist | Hospital Arnau de Villanova (Lérida) | Principal Investigator |
| Vicente Alonso, Oncologist | Hospital Miguel Servet | Principal Investigator |
| María José Safont, Oncologist | Hospital General Universitario de Valencia | Principal Investigator |
| Ruth Vera, Oncologist | Hospital de Navarra | Principal Investigator |
| Pilar Escudero, Oncologist | Hospital Clínico Universitario Lozano Blesa | Principal Investigator |
| Joan Maurel, Oncologist | Hospital Clinic of Barcelona | Principal Investigator |
| Jorge Aparicio, Oncologist | Hospital La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain | ||
| Hospital del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25209376 | Derived | Fernandez-Martos C, Brown G, Estevan R, Salud A, Montagut C, Maurel J, Safont MJ, Aparicio J, Feliu J, Vera R, Alonso V, Gallego J, Martin M, Pera M, Sierra E, Serra J, Delgado S, Roig JV, Santos J, Pericay C. Preoperative chemotherapy in patients with intermediate-risk rectal adenocarcinoma selected by high-resolution magnetic resonance imaging: the GEMCAD 0801 Phase II Multicenter Trial. Oncologist. 2014 Oct;19(10):1042-3. doi: 10.1634/theoncologist.2014-0233. Epub 2014 Sep 10. |
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| Oxaliplatin | Drug | IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks) |
|
| Bevacizumab | Drug | IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks) |
|
|
| Radiotherapy | Radiation | Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks). |
|
|
| Capecitabine during all Radiotherapy period | Drug | 825 mg/m2 bid |
|
|
| Total Mesorectal Excision (TME) | Procedure | 4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after |
|
| Toxicity of treatment | At least 3 years for local recurrence and systemic recurrence |
| Rate of surgical complications during postoperative | At least 3 years for local recurrence and systemic recurrence |
| Profile of gene expression before neoadjuvant treatment | At least 3 years for local recurrence and systemic recurrence |
| Complete Phatologic Response (pCR) | Complete pathologic response (pCR)estimated according to the number of subjects that showed yPT0N0 divided by the total number of subjects. | 2012 |
| Jaime Feliú, Oncologist | Hospital La Paz | Principal Investigator |
| Mengual, Radiotherapy | Instituto Valenciano de Oncología (IVO) | Principal Investigator |
| Moisés Miraflores, Radiotherapy | Hospital Arnau de Vilanova (Lérida) | Principal Investigator |
| Martín Tejedor Gutierrez, Radiotherapy | Hospital Miguel Servet | Principal Investigator |
| Ana Hernández Machancoses, Radiotherapy | Hospital General Universitario de Valencia | Principal Investigator |
| Fernando Arias de la Vega, Radiotherapy | Hospital de Navarra | Principal Investigator |
| Javier Valencia, Radiotherapy | Hospital Clínico Universitario Lozano Blesa | Principal Investigator |
| Carles Conill, Radiotherapy | Hospital Clinic of Barcelona | Principal Investigator |
| Alejandro Tormo Micó, Radiotherapy | Hospital La Fe | Principal Investigator |
| María Elena Sánchez Santos, Radiotherapy | Hospital La Paz | Principal Investigator |
| Jorge Campos, Surgeon | Instituto Valenciano de Oncología (IVO) | Principal Investigator |
| Enrique Sierra Grañón, Surgeon | Hospital Arnau de Vilanova (Lérida) | Principal Investigator |
| Andrés Monzón, Surgeon | Hospital Miguel Servet | Principal Investigator |
| José Vicente Roig, Surgeon | Hospital General Universitario de Valencia | Principal Investigator |
| Javier Suárez Alecha, Surgeon | Hospital de Navarra | Principal Investigator |
| Eloy Tejero, Surgeon | Hospital Clínico Universitario Lozano Blesa | Principal Investigator |
| Antonio Lazy, Surgeon | Hospital Clinic of Barcelona | Principal Investigator |
| Rafael Estevan, Surgeon | Hospital La Fe | Study Director |
| Damián García Olmo, Surgeon | Hospital La Paz | Principal Investigator |
| Jesús Santos, Radiologist | Instituto valenciano de Oncología (IVO) | Principal Investigator |
| Ana Darnell, Radiologist | Complejo Sanitario Parc Taulí | Study Director |
| Luís Sarriá, Radiologist | Hospital Miguel Servet | Principal Investigator |
| Vicente Martínez Sanjuán, Radiologist | Hospital General Universitario de Valencia | Principal Investigator |
| Javier Jiménez, Radiologist | Hospital de Navarra | Principal Investigator |
| José Antonio Fernández Gómez, Radiologist | Hospital Clínico Universitario Lozano Blesa | Principal Investigator |
| Juan Ramón Ayuso, Radiologist | Hospital Clinic of Barcelona | Principal Investigator |
| Fernando Mas Estellés, Radiologist | Hospital La Fe | Principal Investigator |
| Paula Alegría Hidalgo, Radiologist | Hospital La Paz | Principal Investigator |
| Anna Caltrava, Pathologist | Instituto Valenciano de Oncología (IVO) | Study Director |
| Alex Casalots, Pathologist | Complejo Sanitario de Parc Taulí | Principal Investigator |
| Xavier Matias-Guiu Guia, Pathologist | Hospital Arnau de Vilanova (Lérida) | Principal Investigator |
| Carlos Hörndler, Pathologist | Hospital Miguel Servet | Principal Investigator |
| Encarna Martínez, Pathologist | Hospital General Universitario de Valencia | Principal Investigator |
| María Luisa Gómez Dorronsoro, Pathologist | Hospital de Navarra | Principal Investigator |
| Javier Ortego, Pathologist | Hospital Clinico Universitario Lozano Blesa | Principal Investigator |
| María José Artes, Pathologist | Hospital La Fe | Principal Investigator |
| Marta Martín Richard, Oncologist | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Manuel Gallén, Oncologist | Hospital del Mar | Principal Investigator |
| Javier Gallego, Oncologist | Hospital General Universitario de Elche | Principal Investigator |
| Barcelona |
| Barcelona |
| 08003 |
| Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | Barcelona | 08025 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Complejo Sanitario Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital Arnau de Vilanova | Lleida | Lérida | 25198 | Spain |
| Hospital La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital de Navarra | Pamplona | Pamplona | 31008 | Spain |
| Hospital La Fe | Valencia | Valencia | 46009 | Spain |
| Instituto Valenciano de Oncología (IVO) | Valencia | Valencia | 46009 | Spain |
| Hospital General de Valencia | Valencia | Valencia | 46014 | Spain |
| Hospital Miguel Servet | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| D011878 | Radiotherapy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| 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 |
| 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 |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
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