Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
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ClinicalTrials.gov Identifier: NCT01613469
Recruitment Status : Unknown
Verified April 2015 by Marks, John, M.D.. Recruitment status was: Recruiting
This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.
Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of 5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good success in achieving complete clinical response, avoiding surgical intervention. If at follow-up remaining disease is found or if there is recurrent disease, surgery can be performed.
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.
Radiation: external beam photon radiation
45 Gy in 25 fractions (1.8Gy per fraction, 5 fractions per week)over 5 weeks.
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.
Secondary Outcome Measures :
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
over 18 years old
tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed
clinical/radiological stages T2,T3,or T4, N0-1
ANC >1500, PLT>100,000
AST and alkaline phosphatase < 2.5 X ULN
bilirubin < 1.5 X ULN
CrCl > 50 ml/min using Cockcroft-Gault formula
ECOG Performance Scale 0-2
No malignancies within previous 5 years other than non-melanoma skin cancer, in-situ cervical cancer, in-situ ductal breast cancer
no evidence of metastatic disease
initial tumor fixation to pelvic bone or side wide; technically unresectable disease