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Association details:
| Biomarker: | KRAS wild-type |
|---|---|
| Cancer: | Rectal Cancer |
| Drug: | Vectibix (panitumumab) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Rectal cancer: Systemic therapy for advanced or metastatic disease...FOLFOX + panitumumab (KRAS/NRAS/BRAF WT only)...FOLFIRI + panitumumab (KRAS/NRAS/BRAF WT only)...FOLFIRINOX or mFOLFIRINOX + panitumumab...Irinotecan + panitumumab (KRAS/NRAS/BRAF WT only)
Secondary therapy:
FOLFIRINOX; FOLFIRI; FOLFOX; irinotecan
Source:
Title:
Phase II study of pre-operative treatment with external radiotherapy plus panitumumab in operable locally advanced rectal cancer (favourable and intermediate prognostic group) (RaP Study/STAR-03) Studio di fase II sul trattamento pre-operatorio con radioterapia esterna e panitumumab in pazienti con tumore del retto in stadio localmente avanzato, operabile, a prognosi favorevole o intermedia (Studio RaP/STAR-03)
Excerpt:
...Histologically diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge); KRAS wild type; age ≥18 years; Karnofsky performance status of ≥70 at study entry; clinical stage T3 N- M0 or cT2-T3 N+ M0 - CRM; hemoglobin ≥ 9 g/dl; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; bilirubin level < 1.5 ULN; ASAT and ALAT <= 2.5 x ULN; serum creatinine < 1.5 x ULN; magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal; effective contraception for both, male and female patients if the risk of conception exists; signed and dated written informed consents Diagnosi Istologica di adenocarcinoma del retto medio-basso (entro 12 cm dal margine anale); KRAS wild-type; Età≥ 18 anni; Karnofsky performance status ≥70 all'inizio dello studio; stadio clinico T3 N-M0 o CT2-T3 N + M0 - CRM; emoglobina ≥ 9 g / dl; neutrofili ≥1,5 x 10^9 / L; piastrine ≥ 100 x 10^9 / L; livello di bilirubina <1,5 ULN; ASAT e ALAT <= 2,5 x ULN; creatinina sierica < 1,5 x ULN; magnesio ≥ limite inferiore del normale; calcio ≥ limite inferiore del normale; contraccettivo efficace per entrambi, pazienti maschi e femmine se il rischio di concepimento esiste; consenso informato scritto firmato e datato....
Trial ID:
Source:
Title:
Preoperative Panitumumab and Radiotherapy in Rectal Cancer
Excerpt:
...- Wild-type KRAS...
Trial ID:
More C2 evidence
Source:
Title:
Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)
Excerpt:
......
Trial ID:
Source:
Title:
Neoadjuvant Radiochemotherapy Combined With Panitumumab in Locally Advanced KRAS Wild-type Rectal Cancer
Excerpt:
...- Wild-type KRAS....
Trial ID:
Source:
Title:
VECTIBIX PLUS OXALIPLATIN-BASED ADJUVANT TREATMENT OF RECTAL CANCER
Excerpt:
...All the following must be met• Written Informed consent• Adult patients with resected rectal cancer, stage 2 and 3• Wild-type kRAS tumor status• Age > 18• Adequate PS <2• Resection of rectal cancer preceded by chemo-irradiation; there should be at least 3 weeks of postoperative recovery allowed before initiation of adjuvant treatment. ...
Trial ID:
Source:
Title:
Multizentrische Phase 2-Studie zur neoadjuvanten Radiochemotherapie in Kombination mit Panitumumab bei lokal fortgeschrittenem Rektumkarzinom mit Nachweis von KRAS Wild-Typ (NEOREC-1-Studie)
Excerpt:
...o Histologically confirmed, potentially resectable rectal adenocarcinoma staged as uT3/4 N0/1 by endosonography or cT3/4 by MRI of the pelvis with or without local lymph node metastases.o Wild-type KRAS.o ECOG-performance status 0 or 1.o Age ≥ 18 years.o Laboratory requirements:- Haematology: Leucocyte count > 3,000/mm³, neutrophil count ≥1.5x109/L, hemoglobin ≥ 8 g/dL, platelet count ≥100x109/L.- Hepatic Function: Total bilirubin ≤ 1.5 time the upper normal limit (UNL), ASAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases, ALAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases- Renal Function: Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5xUNL- Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.o Negative ß-HCG-serum pregnancy test (females of child bearing potential).o Willing to use double-barrier contraception during study and for 6 months after the end of treatment. ...
Trial ID:
