Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

August 14, 2018 updated by: Marks, John, M.D.

Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 5FU/Leucovorin- post distal rectal srgy
Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer
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.
Other Names:
  • SOC intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
Time Frame: One year from the time of chemoradiation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects with complete pathological response at surgical resection
Time Frame: One year from chemoradiation therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marks, John, M.D.

Investigators

  • Principal Investigator: John Marks, MD, Main Line Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

March 16, 2017

Study Completion (ACTUAL)

March 16, 2017

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (ESTIMATE)

June 7, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R12-3092L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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