Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Colorectal Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/18/2018 |
| Start Date: | August 2011 |
| End Date: | March 16, 2017 |
Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
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.
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.
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
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