Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

• Status: Terminated
• Trial end date: 2017-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marks, John, M.D.
• Treatments: Leucovorin

Criteria

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