Rectal Neoplasms
Conditions
Keywords
fluorouracil, leucovorin, radiotherapy, neoadjuvant therapy
Brief 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.
Detailed 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.
Interventions
DRUG5FU/Leucovorin
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.
Sponsors
Marks, John, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer. | 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
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with complete pathological response at surgical resection | 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. |
Countries
United States
Outcome results
None listed