Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

NCT01613469 | Terminated Phase 2

• 1 other identifier: R12-3092L
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Keywords

fluorouracil; leucovorin; radiotherapy; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The proportion of subjects with complete pathological response at surgical resection

  One year from chemoradiation therapy

Study Arms (1)

5FU/Leucovorin- post distal rectal srgy

OTHER

Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer

Drug: 5FU/Leucovorin

Interventions

5FU/Leucovorin DRUG

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.

Also known as: SOC intervention

5FU/Leucovorin- post distal rectal srgy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marks, John, M.D.: lead

Study Sites (1)

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Related Publications (6)

• 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.

  PMID: 15532809 BACKGROUND

• 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.

  PMID: 9749491 BACKGROUND

• 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.

  PMID: 15623449 BACKGROUND

• 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.

  PMID: 19934911 BACKGROUND

• 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.

  PMID: 19160360 BACKGROUND

• 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.

  PMID: 16550556 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• John Marks, MD

  Main Line Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: August 1, 2011
• Primary Completion: March 16, 2017
• Study Completion: March 16, 2017
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

US (1)