Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer (NARC)

January 5, 2011 updated by: Sun Yat-sen University

A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown.

PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.

Secondary

  • Compare the side effect of chemo radiotherapy according to the Common Toxicity Criteria(CTC) version 2.0 in patients treated with these regimens.
  • Compare the postoperative complications in patients treated with these regimens.
  • Compare the recurrent rate in patients treated with these regimens.
  • Compare the distant metastatic rate in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter clinical trial. Patients are stratified according to participating center, gender, age. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation.
  • Arm II: Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for at least 3 years.

The side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate and 5-year survival rate will be investigated.

PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 5 year.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Ping Lan, M.D.
  • Phone Number: 008613710316769
  • Email: lpzm@yahoo.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Gastrointestinal Hospital, Sun Yat-sen University
        • Contact:

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of Adenocarcinoma of the rectum
  2. Age:18-80 years old
  3. Received curative resection when diagnosed as rectal cancer
  4. Local recurrence happened >6 months after operation,without distant metastasis

  5. Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days prior recruit, meet the following criteria:

    • Hematopoietic
    • Absolute neutrophil count ≥ 1,500/mm^3
    • Platelet count ≥ 100,000/mm^3
    • Hepatic
    • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
    • Alkaline phosphatase ≤ 2 times ULN
    • AST ≤ 2.5 times ULN
    • ALT ≤ 2.5 times ULN
    • No hepatic disease that would preclude study treatment or follow-up
    • No uncontrolled coagulopathy
    • Renal
    • Creatinine clearance > 50 mL/min
    • No renal disease that would preclude study treatment or follow-up

7.ECOG status: 0～1

Exclusion Criteria:

  1. Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
  2. Synchronous colon cancer
  3. Hypersensitivity to fluorouracil
  4. No More than 4 weeks since prior participation in any investigational drug study
  5. Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
  6. History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
  7. Uncontrolled hypertension
  8. Cardiovascular disease that would preclude study treatment or follow-up
  9. Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
  10. Pregnant or nursing, Fertile patients do not use effective contraception
  11. Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
  12. No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Surgical resection and adjuvant therapy
Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation
Procedure: surgical resection and adjuvant therapy

Postoperative:

Drug: fluorouracil Given IV continuously, Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks
EXPERIMENTAL: Neoadjuvant followed by operation
Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation.
Procedure: Neoadjuvant followed by operation

Preoperative:

Drug: fluorouracil Given IV continuously,Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks

Postoperative:

Drug: fluorouracil Given IV continuously,Irinotecan Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year disease free survival
Time Frame: 5 years
Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate,biomarkers, quality of life, toxic profile, convenience
Time Frame: 5 years
  • Compare the postoperative complications in patients treated with these regimens
  • Compare the recurrent rate in these patients
  • Compare the distant metastatic rate in these patients
  • Compare preoperative quality of life (QOL) of patients.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the convenience of care in patients treated with these regimens
5 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

Guangdong Provincial People's Hospital
Second Military Medical University

Investigators

  • Study Director: Ping Lan, M.D., Sun Yat-sen University

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

December 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 5, 2011

First Posted (ESTIMATE)

January 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIHSYSU02

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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