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Association details:
| Biomarker: | KRAS wild-type |
|---|---|
| Cancer: | Colon Cancer |
| Drug: | Erbitux (cetuximab) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Colon Cancer...SYSTEMIC THERAPY FOR ADVANCED OR METASTATIC DISEASE - CHEMOTHERAPY REGIMENS...FOLFIRINOX or mFOLFIRINOX + cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only)...Irinotecan + cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only)...FOLFOX + cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only)...FOLFIRI + cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only)
Secondary therapy:
FOLFIRINOX; FOLFOX; irinotecan; FOLFIRI
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:
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:
More C2 evidence
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:
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:
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:
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:
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:
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:
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:
Optimal Control of Liver Metastases From Colorectal Cancer With Cetuximab and Hepatic Artery Infusion of Chemotherapy
Excerpt:
...- Patient with wild type (WT) KRAS tumor status...
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:
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:
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:
