Title
Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Phase
Phase 2Lead Sponsor
Marks, John, M.D.Study Type
InterventionalStatus
TerminatedIndication/Condition
Rectal NeoplasmsIntervention/Treatment
fluorouracil leucovorin ...Study Participants
5This 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.
Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer
Inclusion Criteria: 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 KPS >60 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 Exclusion Criteria: initial tumor fixation to pelvic bone or side wide; technically unresectable disease any evidence of distant metastasis perforation obstruction hereditary non-polyposis colorectal cancer synchronous primary colon carcinomas except T1 lesions known dihydropyrimidine dehydrogenase deficiency prior radiation therapy to the pelvis prior chemotherapy for malignancies known existing uncontrolled coagulopathy pregnancy or lactation women of childbearing potential not using reliable and appropriate contraceptive method serious, uncontrolled concurrent infection(s) participation in any investigational drug study within 4 weeks preceding the start of study treatment clinically significant heart disease other serious uncontrolled medical conditions that might compromise study participation (in the investigator's opinion) major surgery within 4 weeks prior to the study treatment lack of physical integrity of the upper GI tract or malabsorption syndrome
