Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01613469
• Other study ID #: R12-3092L
• Status: Terminated
• Phase: Phase 2
• Start date: August 2011
• Est. completion date: March 16, 2017

Study information

• Verified date: August 2018
• Source: Marks, John, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 16, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Drug:
• 5FU/Leucovorin
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.

Locations

Country	Name	City	State
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Marks, John, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, São Julião 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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