Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Marks, John, M.D.
Sponsor:
Information provided by (Responsible Party):
Marks, John, M.D.
ClinicalTrials.gov Identifier:
NCT01613469
First received: June 5, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Rectal Neoplasms
Drug: 5FU/Leucovorin
Radiation: external beam photon radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Marks, John, M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year from chemoradiation therapy ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 35
Study Start Date: August 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Radiation: external beam photon radiation
    45 Gy in 25 fractions (1.8Gy per fraction, 5 fractions per week)over 5 weeks.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613469

Contacts
Contact: John Marks, MD 610-645-9093

Locations
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: John Marks, MD    610-645-9093      
Principal Investigator: John Marks, MD         
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: John Marks, MD    610-645-9093      
Sponsors and Collaborators
Marks, John, M.D.
Investigators
Principal Investigator: John Marks, MD Main Line Health
  More Information

Publications:
Responsible Party: Marks, John, M.D.
ClinicalTrials.gov Identifier: NCT01613469     History of Changes
Other Study ID Numbers: R12-3092L
Study First Received: June 5, 2012
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Marks, John, M.D.:
fluorouracil
leucovorin
radiotherapy
neoadjuvant therapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014