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Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

5FU/Leucovorin

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring fluorouracil, leucovorin, radiotherapy, neoadjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lankenau Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

5FU/Leucovorin- post distal rectal srgy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01613469

First Posted

June 5, 2012

Last Updated

August 14, 2018

Sponsor

Marks, John, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT01613469

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Re-eval of patient population

Study Start Date

August 2011 (undefined)

Primary Completion Date

March 16, 2017 (Actual)

Study Completion Date

March 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Marks, John, M.D.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Neoplasms

Keywords

fluorouracil, leucovorin, radiotherapy, neoadjuvant therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5FU/Leucovorin- post distal rectal srgy

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

5FU/Leucovorin

Other Intervention Name(s)

SOC intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.

Description

Time Frame

One year from the time of chemoradiation

Secondary Outcome Measure Information:

Title

The proportion of subjects with complete pathological response at surgical resection

Description

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.

Time Frame

One year from chemoradiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Marks, MD

Organizational Affiliation

Main Line Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lankenau Medical Center

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15532809

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.

Results Reference

background

PubMed Identifier

9749491

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.

Results Reference

background

PubMed Identifier

15623449

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.

Results Reference

background

PubMed Identifier

19934911

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.

Results Reference

background

PubMed Identifier

19160360

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.

Results Reference

background

PubMed Identifier

16550556

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.

Results Reference

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Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

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