Locally advanced RAS wildtype rectal cancer (clinical stage II and III) MedDRA version: 14.1 Level: PT Classification code 10038050 Term: Rectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10038049 Term: Rectal cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Locally advanced rectal cancer (stage II or III; EUS and MRI mandatory) • RAS wildtype mandatory (to be determined at accredited local laboratory or pathology of Mannheim Univ.) • RAS wild-type tested in ? KRAS exon 2 (codons 12/13) ? KRAS exon 3 (codons 59/61) ? KRAS exon 4 (codons 117/146) ? NRAS exon 2 (codons 12/13) ? NRAS exon 3 (codons 59/61) ? NRAS exon 4 (codons 117/146) • PTEN expression result available (IHC - to be determined by pathology of Mannheim Univ.) • adequate hematologic, hepatic, renal and metabolic parameters E. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 58 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: • Distant metastases (excluded by CT scan) • cT4 tumor (excluded by MRI and EUS) • Risk of tumor involvement of the circumferential resection margin, according to the MRI assessment • Sphincter sparing as the major reason for choosing the neoadjuvant treatment approach • Prior antineoplastic therapy for rectal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to estimate the efficacy of panitumumab concurrent to radiotherapy in patients with wild-type RAS. The rate of pathological complete remissions will be compared to expectations derived from historical data.;Secondary Objective: - Safety of the combination (Toxicity assessment according to NCI CTCAE V.3) - Surgical morbidity and complications - Pathological staging, tumor downstaging; assessed by pTNM findings in relation to initial cTNM staging; regression grading according to Dworak - Clinical response (rates of CR/PR/SD/PD after neoadjuvant treatment) - Biomarker studies (KRAS, NRAS, BRAF, PI3K-Akt, PTEN, EGFR);Primary end point(s): pCR rate, defined by the number of patients with a pCR finding divided by the number of patients recruited and having received at least one application of antitumor therapy;Timepoint(s) of evaluation of this end point: At surgical resection of the rectal tumor | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety of the combination (Toxicity assessment according to NCI CTCAE V.4) 2. Surgical morbidity and complications 3. Pathological staging, tumor downstaging; assessed by pTNM findings in relation to initial cTNM staging; regression grading according to Dworak 4. Clinical response (rates of CR/PR/SD/PD after neoadjuvant treatment) 5. Biomarker studies (KRAS, BRAF, PI3K-Akt, PTEN, EGFR);Timepoint(s) of evaluation of this end point: 1. During radio-"immunotherapy" 2. At surgery and 4 weeks after surgery 3. At surgical resection of the rectal tumor 4. At surgical resection of the rectal tumor 5. At inclusion in the study and at surgical resection of the rectal tumor | — |
Countries
Germany
Contacts
Public ContactCRO
WiSP Wissenschaftlicher Service Pharma GmbH
Outcome results
None listed