Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 8:00 PM
Study NCT ID:
NCT01257360
Status:
UNKNOWN
Last Update Posted:
2016-01-13
First Post:
2010-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077544', 'term': 'Panitumumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of pathological complete remissions', 'timeFrame': '15 weeks (average) after start of treatment (at surgery)', 'description': 'The rate of pathological complete remissions is determined after tumor resection following neoadjuvant treatment.'}], 'secondaryOutcomes': [{'measure': 'Toxicity according to NCI CTCAE'}, {'measure': 'Frequency of surgical morbidity and complications', 'timeFrame': 'Within four weeks after surgery'}, {'measure': 'pTNM findings in relation to initial cTNM staging', 'timeFrame': 'At surgery'}, {'measure': 'Regression grading according to Dworak', 'timeFrame': 'At surgery'}, {'measure': 'Clinical response rates (CR/PR/SD/PD) after neoadjuvant treatment', 'timeFrame': 'Before surgery'}, {'measure': 'Correlative biomarker analyses'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RAS-Wildtype', 'Radiotherapy', 'Neoadjuvant treatment'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Staging requirements: trans-rectal endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI)\n* Sufficient representative sample material for RAS analysis\n* Wild-type RAS (determined by an accredited local laboratory, if not available by pathology of Mannheim university)\n\n * RAS wild-type tested in\n\n * KRAS exon 2 (codons 12/13)\n * KRAS exon 3 (codons 59/61)\n * KRAS exon 4 (codons 117/146)\n * NRAS exon 2 (codons 12/13)\n * NRAS exon 3 (codons 59/61)\n * NRAS exon 4 (codons 117/146)\n* Informed consent of the patient\n* Aged at least 18 years\n* WHO Performance Status 0-2\n* Life expectancy of al least 12 weeks\n* Adequate haematological, hepatic, renal and metabolic function parameters:\n\n * Leukocytes \\> 3000/mm³\n * ANC ≥ 1500/mm³\n * Platelets ≥ 100,000/mm³\n * Hb \\> 9 g/dl\n * Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal\n * Bilirubin ≤ 1.5 x upper limit of normal\n * GOT-GPT ≤ 2.5 x upper limit of normal\n * AP ≤ 5 x upper limit of normal\n * Magnesium ≥ lower limit of normal\n * Calcium ≥ lower limit of normal\n\nExclusion Criteria:\n\n* Lower border of the tumor localised more than 12 cm ab ano as measured by rigid rectoscopy\n* Distant metastases (to be excluded by CT scan of the thorax and abdomen)\n* cT4 tumor (as determined by MRI and/or endorectal ultrasound)\n* Risk of tumor involvement of the circumferential resection margin, according to the MRI assessment\n* Sphincter sparing is the major reason for choosing the neoadjuvant treatment approach\n* Prior antineoplastic therapy for rectal cancer\n* Prior radiotherapy of the pelvic region\n* Major surgery within the last 4 weeks prior to inclusion\n* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment\n* 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)\n* Serious concurrent diseases\n* On-treatment participation in a clinical study in the period 30 days prior to inclusion\n* Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment\n* History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan\n* History of HIV infection\n* 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\n* Known allergic reactions on study medication'}, 'identificationModule': {'nctId': 'NCT01257360', 'acronym': 'NEO-RIT', 'briefTitle': 'Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)', 'organization': {'class': 'OTHER', 'fullName': 'WiSP Wissenschaftlicher Service Pharma GmbH'}, 'officialTitle': 'NEO-RIT - Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)', 'orgStudyIdInfo': {'id': 'WISP_AG52'}, 'secondaryIdInfos': [{'id': '2009-016782-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'GMIHO 009/2009', 'type': 'OTHER', 'domain': 'GMIHO mbH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Panitumumab', 'type': 'DRUG', 'otherNames': ['Vectibix'], 'description': 'Panitumumab 6 mg/kg BW will be administered IV every 2 weeks (q2w) on day -14, 1, 15, 29 (and 43, in case radiotherapy is still ongoing due to delays) of the radiotherapy.'}, {'name': 'Radiation of the pelvis', 'type': 'RADIATION', 'description': 'Radiation is applied at single doses of 1.8 Gy at the ICRU 50 reference point, once daily, five times a week, adding up to 28 fractions over almost 6 weeks and a total reference dose of 50.4 Gy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73780', 'city': 'Esslingen am Neckar', 'country': 'Germany', 'facility': 'Klinikum Esslingen Klinik für Onkologie, Gastroenterologie und Allgemeine Innere Medizin', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Klinik für Strahlentherapie und Onkologie, Universitätsklinikum Frankfurt am Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '74078', 'city': 'Heilbronn', 'country': 'Germany', 'facility': 'SLK-Kliniken Heilbronn GmbH Medizinische Klinik III', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Tagestherapiezentrum am ITM & III. Medizinische Klinik, Universitätsmedizin Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '45659', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Prosper Hospital Medizinische Klinik I', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}], 'overallOfficials': [{'name': 'Ralf Hofheinz, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tagestherapiezentrum am ITM & III. Medizinische Klinik, Universitätsmedizin Mannheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WiSP Wissenschaftlicher Service Pharma GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}