Public trial
RBR-5j3j9z9 Chemoradiation and Consolidation Chemotherapy with or without oxaliplatin for distal rectal cancer and Watch and Wait. A...
Date of registration: 02/10/2021 (mm/dd/yyyy)Last approval date : 02/10/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Chemoradiation and Consolidation Chemotherapy with or without oxaliplatin for distal rectal cancer and Watch and Wait. A multi-center prospective randomized controlled trial. (CCHOWW)
pt-br
Quimiorradioterapia e quimioterapia de consolidação com ou sem oxaliplatina para câncer de reto distal e Watch and Wait. (CCHOWW)
es
Quimiorradioterapia y Quimioterapia de consolidación con o sin oxaliplatino para el cáncer de recto distal y Watch and wait. Estudio multicéntrico, prospectivo y aleatorio. (CCHOWW)
Trial identification
- UTN code:
-
Public title:
en
Chemoradiation and Consolidation Chemotherapy with or without oxaliplatin for distal rectal cancer and Watch and Wait. A multi-center prospective randomized controlled trial. (CCHOWW)
pt-br
Quimiorradioterapia e quimioterapia de consolidação com ou sem oxaliplatina para câncer de reto distal e Watch and Wait. (CCHOWW)
es
Quimiorradioterapia y Quimioterapia de consolidación con o sin oxaliplatino para el cáncer de recto distal y Watch and wait. Estudio multicéntrico, prospectivo y aleatorio. (CCHOWW)
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Scientific acronym:
en
CCHOWW
pt-br
CCHOWW
es
CCHOWW
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Public acronym:
en
CCHOWW
pt-br
CCHOWW
es
CCHOWW
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Secondaries identifiers:
-
U1111-1264-5301
Issuing authority:
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U1111-1264-5301
Sponsors
- Primary sponsor: Hospital Alemão Oswaldo Cruz
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Secondary sponsor:
- Institution: Hospital Alemão Oswaldo Cruz
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Supporting source:
- Institution: Hospital Alemão Oswaldo Cruz
Health conditions
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Health conditions:
en
rectal cancer
pt-br
câncer de reto
es
cáncer del recto
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General descriptors for health conditions:
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Specific descriptors:
en
D011878
en
D060830-54680 Consolidation chemotherapy
pt-br
D060830-54680 Quimioterapia de consolidação
es
D060830-54680 Quimioterapia de Consolidación
Interventions
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Interventions:
en
Patients with distal rectal cancer will be randomly assigned to receive neoadjuvant chemoradiation with consolidation chemotherapy using 1 or 2 drugs during the consolidation treatment: 2 drugs arm: RT (54Gy) plus daily concomitant capecitabine 825mg/m2 bid, followed by mFOLFOX6 or XELOX for 4 cycles (12 weeks), starting 1 week after radiotherapy ended; 1 drug arm: RT (54Gy) plus daily concomitant capecitabine 825mg/m2 bid, followed by capecitabine 2000mg/m2/day for 14 days in a 21 days cycle for 4 cycles (12 weeks), starting 1 week after radiotherapy ended;
pt-br
Pacientes com cancer de reto distal serão randomizados para receber quimiorradioterapia Neoadjuvante com quimioterapia de consolidação usando 1 ou 2 drogas: braço com 2 drogas: RT (54Gy) com capecitabina 825mg/m2 diário concomitante duas vezes por dia, seguido de mFOLFOX6 ou XELOX por 4 ciclos (12 semanas), começando 1 semana depois do término da radioterapia; braço com 1 droga: RT (54Gy) com capecitabina 825mg/m2 diário concomitante duas vezes por dia, seguido de capecitabina 2000mg/m2/dia por 14 dias em ciclos de 21 dias por 4 ciclos (12 semanas), começando 1 semana depois do término da radioterapia
es
Pacientes con cáncer de recto distal serán aleatorizados para recibir quimiorradioterapia neoadyuvante con quimioterapia de consolidación utilizando 1 o 2 fármacos: brazo con 2 fármacos: RT (54 Gy) con capecitabina 825 mg / m2 concomitante al día dos veces al día, seguido de mFOLFOX6 o XELOX durante 4 ciclos (12 semanas), comenzando 1 semana después del final de la radioterapia; brazo con 1 fármaco: RT (54 Gy) con capecitabina 825 mg / m2 concomitante al día dos veces al día, seguida de capecitabina 2000 mg / m2 / día durante 14 días en ciclos de 21 días durante 4 ciclos (12 semanas), comenzando 1 semana después del final de la radioterapia
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Descriptors:
en
E02.319.218 Consolidation Chemotherapy
pt-br
E02.319.218 Quimioterapia de consolidação
es
E02.319.218 Quimioterapia de Consolidación
Recruitment
- Study status: Not yet recruiting
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Countries
- Brazil
- Argentina
- Colombia
- Costa Rica
- Panama
- Date first enrollment: 01/04/2021 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 216 - 18 Y 0 -
Inclusion criteria:
en
1. Age ≥18 years; 2. ECOG 0-2 or KPS≥70; 3. Primary rectal adenocarcinoma (biopsy confirmed) within the reach of digital rectal examination (at least lower tip/border) by the attending colorectal surgeon; 4. Endoscopic documentation; 5. Abdominal and chest CT scans showing no evidence of metastatic disease; 6. High-resolution magnetic resonance images performed at either 1.5T or 3.0T system using a phased array surface coil with: sagittal T2 images including the anal verge and the sacrum; axial oblique T2 weighted images acquired in a plane perpendicular to the long axis of the rectal wall guided by the sagittal images; coronal images acquired in parallel to the anal canal plane. Small field of view (16-18cm), 3mm section thickness, increased matrix size and increased number of signal averages are required; 7. Radiological defining criteria (centralized): a. Lower edge of tumor at the level (max. 1cm distance) or below the anorectal ring defined at sagittal or coronal views; b. mrT2, mrT3 (any subclassification) c. mrN0-1 (≤3 radiologically positive lymph nodes) d. mrEMVI: any status e. mrMRF: any status
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Exclusion criteria:
en
1. Pregnancy 2. ECOG ≥3 or KPS<70 3. Unwilling to consent 4. Metastatic disease (any kind; internal iliac and obturator nodes are considered local disease and not metastatic disease and therefore will not be considered as exclusion criteria) 5. mrT4 or mrN2 6. Previous pelvic irradiation 7. Baseline neuropathy 8. Receiving treatment of other anti-cancer drug or methods 9. Presence of uncontrolled life threatening diseases
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Parallel 2 Open Randomized-controlled 3
Outcomes
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Primary outcomes:
en
Decision to Watch and Wait due to clinical complete response achieved at 18 weeks from last date of radiation using clinical (DRE), endoscopic and radiological criteria (mrTRG grade) or near-complete clinical response (no progressive disease clinically, endoscopically or radiologically)
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Secondary outcomes:
Contacts
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Public contact
- Full name: Guilherme Pagin São Julião
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- Address: Praça Amadeu Amaral, 47 cj 111
- City: São Paulo / Brazil
- Zip code: 01327-010
- Phone: (11) 996343780
- Email: guilhermepc91@gmail.com
- Affiliation:
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Scientific contact
- Full name: Guilherme Pagin São Julião
-
- Address: Praça Amadeu Amaral, 47 cj 111
- City: São Paulo / Brazil
- Zip code: 01327-010
- Phone: (11) 996343780
- Email: guilhermepc91@gmail.com
- Affiliation:
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Site contact
- Full name: Guilherme Pagin São Julião
-
- Address: Praça Amadeu Amaral, 47 cj 111
- City: São Paulo / Brazil
- Zip code: 01327-010
- Phone: (11) 996343780
- Email: guilhermepc91@gmail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 16963.
Existem 8360 ensaios clínicos registrados.
Existem 4701 ensaios clínicos recrutando.
Existem 237 ensaios clínicos em análise.
Existem 5772 ensaios clínicos em rascunho.