Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

NCT ID: NCT01613469

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-03-16

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.

Conditions

Rectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5FU/Leucovorin- post distal rectal srgy

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

Group Type: OTHER

5FU/Leucovorin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

SOC intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marks, John, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Marks, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health

Locations

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15532809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9749491 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15623449 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19934911 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19160360 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16550556 (View on PubMed)

Other Identifiers

R12-3092L

Identifier Type: -

Identifier Source: org_study_id