Maintenance Chemotherapy After 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.

Sex

All

Minimum age

18 Years

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

• BACKGROUNDHabr-Gama A, Perez RO, Kiss DR, Rawet V, Scanavini A, Santinho PM, Nadalin W. Preoperative chemoradiation therapy for low rectal cancer. Impact on downstaging and sphincter-saving operations. Hepatogastroenterology. 2004 Nov-Dec;51(60):1703-7. PMID 15532809
• BACKGROUNDHabr-Gama A, de Souza PM, Ribeiro U Jr, Nadalin W, Gansl R, Sousa AH Jr, Campos FG, Gama-Rodrigues J. Low rectal cancer: impact of radiation and chemotherapy on surgical treatment. Dis Colon Rectum. 1998 Sep;41(9):1087-96. doi: 10.1007/BF02239429. PMID 9749491
• BACKGROUNDHabr-Gama A, Perez RO, Nadalin W, Nahas SC, Ribeiro U Jr, Silva E Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Long-term results of preoperative chemoradiation for distal rectal cancer correlation between final stage and survival. J Gastrointest Surg. 2005 Jan;9(1):90-9; discussion 99-101. doi: 10.1016/j.gassur.2004.10.010. PMID 15623449
• BACKGROUNDHabr-Gama A, Perez RO, Sabbaga J, Nadalin W, Sao Juliao GP, Gama-Rodrigues J. Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period. Dis Colon Rectum. 2009 Dec;52(12):1927-34. doi: 10.1007/DCR.0b013e3181ba14ed. PMID 19934911
• BACKGROUNDHabr-Gama A, Perez RO. Non-operative management of rectal cancer after neoadjuvant chemoradiation. Br J Surg. 2009 Feb;96(2):125-7. doi: 10.1002/bjs.6470. No abstract available. PMID 19160360
• BACKGROUNDPetersen S, Hellmich G, von Mildenstein K, Porse G, Ludwig K. Is surgery-only the adequate treatment approach for T2N0 rectal cancer? J Surg Oncol. 2006 Apr 1;93(5):350-4. doi: 10.1002/jso.20452. PMID 16550556