Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
18 Years
N/A
Both
Rectal Neoplasms
Trial Information
Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
Outcome Description:
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.
Outcome Time Frame:
One year from the time of chemoradiation
Safety Issue:
No
Principal Investigator
John Marks, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Main Line Health
Authority:
United States: Food and Drug Administration
Study ID:
R12-3092L
NCT ID:
NCT01613469
Start Date:
August 2011
Completion Date:
August 2014
Related Keywords:
- Rectal Neoplasms
- fluorouracil
- leucovorin
- radiotherapy
- neoadjuvant therapy
- Neoplasms
- Rectal Neoplasms
Name | Location |
|---|---|
| Lankenau Medical Center | Wynnewood, Pennsylvania 19096 |
