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)

Phase 1

Conditions: Operable locally advanced rectal cancer
MedDRA version: 14.1Level: LLTClassification code 10038019Term: Rectal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-000649-20-IT

Lead Sponsor: FONDAZIONE DELL'ISTITUTO TOSCANO TUMORI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 92

Inclusion Criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

Prior radiotherapy or chemotherapy for rectal cancer; concurrent chronic systemic immune therapy; any investigational agent(s); previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy; clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months; known grade 3 or 4 allergic reaction to any of the components of the treatment; known drug abuse/ alcohol abuse; legal incapacity or limited legal capacity; medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed; women who are pregnant or breastfeeding consent; acute or subacute gastro-intestinal occlusion; any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the trial)