Panitumimab in combination with radiotherapy in patients with locally advanced RAS wildtype rectal cancer (clinical stages II and III)
- Conditions
- ocally advanced RAS wildtype rectal cancer (clinical stage II and III)MedDRA version: 14.1Level: PTClassification code 10038050Term: Rectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10038049Term: Rectal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-016782-28-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to estimate the efficacy of panitumumab concurrent to radiotherapy in<br>patients with wild-type RAS. The rate of pathological complete remissions will be compared to expectations<br>derived from historical data.;Secondary Objective: - Safety of the combination (Toxicity assessment according to NCI CTCAE V.3)<br>- Surgical morbidity and complications<br>- Pathological staging, tumor downstaging; assessed by pTNM findings in<br>relation to initial cTNM staging; regression grading according to Dworak<br>- Clinical response (rates of CR/PR/SD/PD after neoadjuvant treatment)<br>- 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<br>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 Outcome Measures
Name Time Method Secondary end point(s): 1. Safety of the combination (Toxicity assessment according to NCI CTCAE V.4)<br>2. Surgical morbidity and complications<br>3. Pathological staging, tumor downstaging; assessed by pTNM findings in relation to initial cTNM staging; regression grading according to Dworak<br>4. Clinical response (rates of CR/PR/SD/PD after neoadjuvant treatment)<br>5. Biomarker studies (KRAS, BRAF, PI3K-Akt, PTEN, EGFR);Timepoint(s) of evaluation of this end point: 1. During radio-immunotherapy<br>2. At surgery and 4 weeks after surgery<br>3. At surgical resection of the rectal tumor<br>4. At surgical resection of the rectal tumor<br>5. At inclusion in the study and at surgical resection of the rectal tumor