Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT01613469|
Recruitment Status : Terminated (Re-eval of patient population)
First Posted : June 7, 2012
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms||Drug: 5FU/Leucovorin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||March 16, 2017|
|Actual Study Completion Date :||March 16, 2017|
5FU/Leucovorin- post distal rectal srgy
Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer
450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles during radiation (one cycle is the administration every day for 3 consecutive days, a cycle is 21 days)followed by 450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles after completion of radiation.
Other Name: SOC intervention
- To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer. [ Time Frame: One year from the time of chemoradiation ]Primary endpoints are the proportion of subjects with complete clinical response to chemoradiation therapy at no sooner than 9 weeks from treatment completion, and maintenance of continuous freedom from local failure for one year.
- The proportion of subjects with complete pathological response at surgical resection [ Time Frame: One year from chemoradiation therapy ]At surgical intervention for incomplete clinical response or recurrence, complete pathological response is no evidence of residual disease at pathological examination of the resected specimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613469
|United States, Pennsylvania|
|Lankenau Medical Center|
|Wynnewood, Pennsylvania, United States, 19096|
|Principal Investigator:||John Marks, MD||Main Line Health|