Clinical trial NCT01613469: Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Official title: Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rectal Neoplasms
Keywords: fluorouracil
leucovorin
radiotherapy
neoadjuvant therapy
Lead sponsor: Marks, John, M.D.
Sponsor class: INDIV
First posted: 2012-06-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
timeFrame: One year from the time of chemoradiation
Secondary outcomes:
measure: The proportion of subjects with complete pathological response at surgical resection
timeFrame: One year from chemoradiation therapy
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
Study officials:
affiliation: Main Line Health
name: John Marks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habr-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.
citation: Habr-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.
citation: Habr-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.
citation: Habr-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.
citation: Habr-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.
citation: Petersen 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.