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Study 25 of 2431 for search of: | received on or after 11/14/2008 |
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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00795301 |
Primary Objectives To estimate the pathological complete response rate following neoadjuvant radiotherapy with concurrent capecitabine and oxaliplatin, with or without cetuximab based on the KRAS mutation status in rectal cancer.
Secondary Objectives
Condition | Intervention | Phase |
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Rectal Cancer |
Drug: Capecitabine, Cetuximab, Oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Efficacy Study |
Official Title: | A Randomized, Phase II Study of Concurrent Radiotherapy and Oxaliplatin, Capecitabine With or Without Cetuximab in Rectal Cancer Tumor Stratified by KRAS Mutation Status. |
Estimated Enrollment: | 74 |
Study Start Date: | July 2008 |
Aims: The primary aim of this study is to estimate the pathological complete response rate following neoadjuvant radiotherapy with concurrent capecitabine and oxaliplatin (CAPOX), with or without cetuximab based on the KRAS mutation status in rectal cancer.
Hypothesis: Cetuximab, a monoclonal antibody targeted against the EGF receptor, is active in metastatic colorectal cancer and a radio-sensitizer. In colorectal cancer, the presence of KRAS mutation has been associated with the absence of response to cetuximab. We hypothesise that the addition of cetuximab to CAPOX concurrent with neoadjuvant radiotherapy only benefited patients whose tumours do not have the KRAS mutation and therefore, personalizing cetuximab therapy based on tumour KRAS mutation status may yield a higher pathological response.
Methods: This study employed a standard 2-stage Phase II design to evaluate the efficacy and tolerability of two neoadjuvant chemoradiotherapy regimens. The assignment of the neoadjuvant chemotherapy will be determined by the KRAS mutation status of the tumor. Subjects with KRAS mutation will receive CAPOX. Subjects with no KRAS mutation will be randomized to receive CAPOX +/- cetuximab.Definitive surgery is scheduled for 6-8 weeks after the completion of chemoradiotherapy. Surgical management will be a sphincter preservation approach whenever possible, using the total mesorectal excision technique.After the operation, pathologic evaluation of the surgical specimen will be performed.
Significance:In this proof-of-concept study, we aim to demonstrate that using an enriched patient cohort to test our hypothesis that the addition of cetuximab will yield a higher pathological response rate in KRAS mutation-negative rectal cancer. This approach can potentially identify a subset of patients that may benefit from cetuximab and spare those who may not benefit from unnecessary treatment toxicities and costs. Our study will help to prioritise novel targeted agents for a smaller, faster, and less expensive confirmatory phase III trials.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as defined below:
leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) greater than 2.5 X institutional upper limit of normal creatinine within normal institutional limits
Exclusion Criteria:
Contact: Wei Peng Yong, MRCP, MB ChB | 65 6772 4670 | Wei_Peng_Yong@nuhs.edu.sg |
Contact: Ross Andrew Soo, MBBS | 65 6772 4624 | Ross_Soo@nuhs.edu.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore, 119074 | |
Contact: Wei Peng Yong, MRCP, MB ChB 65 6772 4670 Wei_Peng_Yong@nuhs.edu.sg | |
Contact: Ross Andrew Soo, MBBS 65 6772 4624 Ross_Soo@nuhs.edu.sg | |
Principal Investigator: Wei Peng Yong, MRCP, MB ChB |
Principal Investigator: | Wei Peng Yong, MRCP, MB ChB | National University Hospital, Singapore |
Responsible Party: | National University Hospital ( Wei Peng Yong ) |
Study ID Numbers: | CR02/06/07 |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795301 |
Health Authority: | Singapore: Health Sciences Authority |
tumor |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cetuximab Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal neoplasm Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |