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Association details:
| Biomarker: | RAS wild-type |
|---|---|
| Cancer: | Colon Cancer |
| Drug: | Erbitux (cetuximab) (EGFR inhibitor) |
| Direction: | Resistant |
Evidence:
Source:
Title:
A study to evaluate the efficacy and safety of SOT101 in combination with cetuximab in patients with a specific subtype of colon and/or rectum cancer Estudio para evaluar la eficacia y seguridad de SOT101 en combinación con cetuximab en pacientes con un subtipo específico de cáncer de colon y/o recto
Excerpt:
...Histologically or cytologically confirmed advanced and/or metastatic RAS wild-type colorectal cancer as confirmed by the investigational site within 3 months prior to the first administration of study treatment. ...
Trial ID:
Source:
Title:
Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)
Excerpt:
......
Trial ID:
More C2 evidence
Source:
Title:
Observational Study on Second Line Treatment of Liver Metastases With DEBIRI and Cetuximab
Excerpt:
...Patients K-RAS wild type...
Trial ID:
Source:
Title:
Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery
Excerpt:
...- Although KRAS status will be evaluated in the tumor, wild type KRAS status is...
Trial ID:
Source:
Title:
Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.
Excerpt:
...- Signed written informed consent for enrolment (pts with KRAS wild type)...
Trial ID:
Source:
Title:
Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V Studio di fase II sull’utilizzo dell’associazione FOLFIRI+Cetuximab nel trattamento di prima linea dei pazienti affetti da carcinoma del colon-retto avanzato con RAS wild type e FcYRIIIA-V/V
Excerpt:
...• Cytological or histological diagnosis of colorectal adenocarcinoma• wild-type RAS• FcγRIIIa-158V / V genotype• Stage IV• Negative pregnancy test where applicable• Age 3 months• Written informed consent • Diagnosi citologica o istologica di adenocarcinoma del colon-retto • RAS wild-type• Genotipo FcγRIIIa-158V/V • Stadio IV• Test di gravidanza negativo ove applicabile• Età 3 mesi • Consenso informato scritto...
Trial ID:
Source:
Title:
Randomized, open-label phase II study evaluating the safety and efficacy of Cetuximab plus modified FOLFOX - 6 versus modified FOLFOX - 6 alone as 2nd line therapy after progression on the 1st line treatment with Cetuximab + FOLFIRI in patients with metastatic colorectal cancer KRAS wild-type – TAGUS Study
Excerpt:
...- Signed written informed consent- Male or Female with, at least, 18 years old- Histologically or cytologically-proven metastatic adenocarcinoma of the colon or rectum with wild-type KRAS status- Patients treated in 1st line treatment with cetuximab + FOLFIRI- Metastatic disease (M1) not amenable to potentially curative treatment- Presence of at least one unidimensionally measurable lesion with a diameter ≥ 20 mm by conventional CT or magnetic resonance imaging (MRI) or ≥ 10 mm by spiral CT (Target lesion(s) must not lie within an irradiated area)- Life expectancy of at least 3 months- ECOG performance status of 0 or 1 at study entry- Effective contraception for both male and female with reproductive potential while on treatment and for 6 months after study treatment...
Trial ID:
Source:
Title:
Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response
Excerpt:
...- Patient with histologically proven metastatic colorectal cancer with KRAS wild-type...
Trial ID:
Source:
Title:
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Excerpt:
...Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments`Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments...
Trial ID:
Source:
Title:
Pharmacokinetics and Metabolic Activation of Capecitabine
Excerpt:
...- K-ras wild type adenocarcinoma of the colon or rectum...
Trial ID:
Source:
Title:
FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor
Excerpt:
...- Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR...
Trial ID:
Source:
Title:
Alternating chemotherapy plus cetuximab to allow resection of metastases from a colorectal cancer that is wild-type KRAS and BRAF - a randomised phase II trial - Nordic 7.6
Excerpt:
...KRAS and BRAF status - Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF General conditions - age > 18 years - WHO performance status ≤ 1; - expected survival > 3 months - sufficient bone-marrow function (Hb ≥ 6.2 µmol/l/Hb > 10 g/dl ANC ≥ 1.5 x 109/l, thrombocytes ≥ 100 x 109/l) - sufficient kidney and liver function: total bilirubin ≤ 1.5 x upper normal limit, serum creatinine ≤ 1.25 x upper normal limit, ALAT ≤ 3 x upper normal limit and ≤ 5 x upper normal limit with liver metastases - the patient must have signed an informed declaration of consent before being registered; this must be documentable according to national guidelines...
Trial ID:
Source:
Title:
Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab
Excerpt:
...- RAS wild-type tumour status (KRAS and NRAS exon 2-4) (proven in the primary tumour or metastasis) at any timepoint of randomisation...
Trial ID:
Source:
Title:
A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver
Excerpt:
......
Trial ID:
Source:
Title:
Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream
Excerpt:
...- Patients eligible for Erbitux and FOLFIRI treatment K-Ras wild type tumour...
Trial ID:
Source:
Title:
Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery
Excerpt:
...DFS time in the ITT KRAS wild-type population`Disease-free survival...
Trial ID:
Source:
Title:
Nordic 8 - A Phase II Trial
Excerpt:
...- Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF...
Trial ID:
Source:
Title:
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Excerpt:
...The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). ...
Trial ID:
Source:
Title:
Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
Excerpt:
...- Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum, with KRAS wild type on mutational analysis....
Trial ID:
Source:
Title:
FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer
Excerpt:
...- The colorectal primary tumor or metastatic tumor must be determined to be KRAS and NRAS wild-type....
Trial ID:
Source:
Title:
Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer
Excerpt:
...eligible malignancies include: colorectal cancer KRAS wild-type and squamous cell head and neck cancer...
Trial ID:
Source:
Title:
Cetuximab Standard or Dose Escalation in First Line Colorectal Cancer
Excerpt:
...K-Ras wild type tumour eligible for treatment with cetuximab....
Trial ID:
Source:
Title:
A Randomized, Placebo-controlled, Double-blind Phase II Study Evaluating if Glucophage Can Avoid Liver Injury Due to Chemotherapy Associated Steatosis
Excerpt:
...- Diagnosis of histologically confirmed, KRAS "wild-type" adenocarcinoma of the colon or rectum...
Trial ID:
Source:
Title:
Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Excerpt:
...Must be KRAS WT; 4....
Trial ID:
Source:
Title:
An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
Excerpt:
...- Subjects with KRAS wild-type status of tumour tissue...
Trial ID:
Source:
Title:
Tumour markers response to chemotherapy in patients with colorectal liver metastases Marcatori di risposta alla chemioterapia in pazienti con metastasi epatiche colorettali
Excerpt:
...Adenocarcinoma del colon-retto istologicamente accertato, k-ras wild type. ...
Trial ID:
Source:
Title:
FLOX + Erbitux. 1. line treatment to patients with metastatic colorectal cancer and wild type K-RAS tumor. A phase II study.
Excerpt:
...Histology and staging disease:• Histological proven adenocarcinoma of the colon or rectum• At least one measurable metastatic lesion according to RECIST criteria• If only one metastatic lesion, histology is mandatoryMutation level:• Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCRGeneral conditions: • Age >18 and 18 and < 75 years • WHO performance status ≤ 2; life expectancy of more than 3 months• Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)• Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases• Written informed consent prior to inclusion must be obtained and documented according to the local regulatory requirementsOther:• Fertile patients must use adequate contraceptives...
Trial ID:
Source:
Title:
A study to explore the effects of cetuximab alone or in combination with irinotecan in patients with an abnormal gene (KRAS) in their colon cancer cells.
Excerpt:
...Prior confirmation of tumour KRAS status as either KRAS WT (with no mutations or changes in BRAF, NRAS, PIK3CA exon20) OR KRAS G13D mutation,6. ...
Trial ID:
Source:
Title:
A randomized phase II study of FOLFORI plus or not CETUXIMAB in elderly advanced colorectal cancer patients. Studio randomizatto di fase II con FOLFIRI piu' CETUXIMAB o FOLFIRI da solo in pazienti anziani affetti da tumore colo-rettale avanzato.
Excerpt:
...Wild-type KRAS tumors. ...
Trial ID:
Source:
Title:
Multicenter prospective single-arm study investigating the efficacy and safety of second-line cetuximab plus chemotherapy treatment in initially RAS-mt mCRC patients who converted to RAS-wt at the time of first progression Studio di fase II a singolo braccio di terapia di II linea con cetuximab e chemioterapia in pazienti con carcinoma colorettale metastatico KRAS e NRAS mutato alla diagnosi con assenza di mutazioni di KRAS/NRAS su plasma alla progressione da prima linea
Excerpt:
...• Consenso informato scritto nella fase di screening e nella fase di arruolamento• KRAS/NRAS wild-type su plasma (DNA tumorale circolante) al momento della progressione da prima linea di trattamento• Aspettativa di vita di almeno 3 mesi...
Trial ID:
Less C2 evidence
Source:
Title:
Primary tumor location predicts poor clinical outcome with cetuximab in RAS wild-type metastatic colorectal cancer
Published date:
11/23/2017
Excerpt:
In RAS wild-type colon cancer treated with cetuximab as salvage treatment, right colon primary was associated with poorer survival outcomes than left colon and rectal cance
Source:
Title:
Lobaplatin hyperthermic intraperitoneal chemotherapy plus cytoreduction and rechallenge using cetuximab for wild-type RAS peritoneal metastatic colon cancer: a case report and literature review
Published date:
02/14/2022
Excerpt:
CONTRADICTING EVIDENCE: A 49 year-old man with signet ring cell carcinoma of sigmoid colon with extensive abdominal metastasis (wild-type RAS)...Capecitabine adjuvant chemotherapy was administered, followed by the maintenance therapy with FOLFIRI + cetuximab regimen. After that, the patient has been in relatively stable condition...the overall survival is more than 45 months, which displays significant curative effect.
Secondary therapy:
FOLFIRI + capecitabine
DOI:
10.1186/s12876-022-02109-z
Source:
Title:
Lobaplatin hyperthermic intraperitoneal chemotherapy plus cytoreduction and rechallenge using cetuximab for wild-type RAS peritoneal metastatic colon cancer: a case report and literature review
Published date:
02/14/2022
Excerpt:
A 49 year-old man with signet ring cell carcinoma of sigmoid colon with extensive abdominal metastasis (wild-type RAS)...After receiving HIPEC with lobaplatin and XELOX regimen combined with cetuximab for eight cycles, the patient had been treated with the FOLFIRI regimen and cetuximab for 24 cycles, which discontinued due to myelosuppression. Because the disease recurred unfortunately 4 months later, the FOLFIRI + cetuximab regimen was initiated again and stopped after two cycles.
Secondary therapy:
D19466; FOLFIRI
DOI:
10.1186/s12876-022-02109-z
