Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Drug: 5FU/Leucovorin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 5FU/Leucovorin- post distal rectal srgy<br>Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer | Drug: 5FU/Leucovorin<br>* 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.<br>* Other names: SOC intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer. | 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. | One year from the time of chemoradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with complete pathological response at surgical resection | 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. | One year from chemoradiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluorouracil, leucovorin, radiotherapy, neoadjuvant therapy