This trial is active, not recruiting.

Condition rectal cancer
Treatments panitumumab, radiation of the pelvis
Phase phase 2
Target EGFR
Sponsor WiSP Wissenschaftlicher Service Pharma GmbH
Collaborator Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Start date December 2010
End date January 2016
Trial size 59 participants
Trial identifier NCT01257360, 2009-016782-28, GMIHO 009/2009, WISP_AG52


The objective of this trial is to obtain evidence that, in patients with RAS wildtype tumors, a chemotherapy-free combined modality treatment with panitumumab is clearly superior to radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy including two-drug combinations while reducing the toxicity compared to these two-drug regimens.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Rate of pathological complete remissions
time frame: 15 weeks (average) after start of treatment (at surgery)

Secondary Outcomes

Toxicity according to NCI CTCAE
time frame:
Frequency of surgical morbidity and complications
time frame: Within four weeks after surgery
pTNM findings in relation to initial cTNM staging
time frame: At surgery
Regression grading according to Dworak
time frame: At surgery
Clinical response rates (CR/PR/SD/PD) after neoadjuvant treatment
time frame: Before surgery
Correlative biomarker analyses
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed diagnosis of locally advanced rectal cancer (stage II or III) localised 0 - 12 cm ab ano as measured by rigid rectoscopy (i.e. lower and middle third of the rectum) - Staging requirements: trans-rectal endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI) - Sufficient representative sample material for RAS analysis - Wild-type RAS (determined by an accredited local laboratory, if not available by pathology of Mannheim university) - 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) - Informed consent of the patient - Aged at least 18 years - WHO Performance Status 0-2 - Life expectancy of al least 12 weeks - Adequate haematological, hepatic, renal and metabolic function parameters: - Leukocytes > 3000/mm³ - ANC ≥ 1500/mm³ - Platelets ≥ 100,000/mm³ - Hb > 9 g/dl - Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal - Bilirubin ≤ 1.5 x upper limit of normal - GOT-GPT ≤ 2.5 x upper limit of normal - AP ≤ 5 x upper limit of normal - Magnesium ≥ lower limit of normal - Calcium ≥ lower limit of normal Exclusion Criteria: - Lower border of the tumor localised more than 12 cm ab ano as measured by rigid rectoscopy - Distant metastases (to be excluded by CT scan of the thorax and abdomen) - cT4 tumor (as determined by MRI and/or endorectal ultrasound) - Risk of tumor involvement of the circumferential resection margin, according to the MRI assessment - Sphincter sparing is the major reason for choosing the neoadjuvant treatment approach - Prior antineoplastic therapy for rectal cancer - Prior radiotherapy of the pelvic region - Major surgery within the last 4 weeks prior to inclusion - Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment - Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly) - Serious concurrent diseases - On-treatment participation in a clinical study in the period 30 days prior to inclusion - Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment - History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan - History of HIV infection - Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free - Known allergic reactions on study medication

Additional Information

Official title NEO-RIT - Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)
Principal investigator Ralf Hofheinz, Prof. Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by WiSP Wissenschaftlicher Service Pharma GmbH.