Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Marks, John, M.D.

Status and phase

Terminated

Phase 2

Conditions

Rectal Neoplasms

Treatments

Drug: 5FU/Leucovorin

Study type

Interventional

Identifiers

NCT01613469

R12-3092L

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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