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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by Sun Yat-sen University
Sponsor:
Collaborators:
Guangdong General Hospital
Second Military Medical University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01271192
First received: January 5, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Rectal Cancer
Procedure: surgical resection and adjuvant therapy
Procedure: Neoadjuvant followed by operation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 5-year disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.


Secondary Outcome Measures:
  • Side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate,biomarkers, quality of life, toxic profile, convenience [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 360
Study Start Date: December 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01271192

Contacts
Contact: Ping Lan, M.D. 008613710316769 lpzm@yahoo.com

Locations
China, Guangdong
Gastrointestinal Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Pang Lan, M.D.    008613710316769    lpzm@yahoo.com   
Sponsors and Collaborators
Sun Yat-sen University
Guangdong General Hospital
Second Military Medical University
Investigators
Study Director: Ping Lan, M.D. Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Ping Lan, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01271192     History of Changes
Other Study ID Numbers: GIHSYSU02
Study First Received: January 5, 2011
Last Updated: January 5, 2011
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
local recurrent rectal cancer
surgical resection
adjuvant therapy

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

ClinicalTrials.gov processed this record on July 24, 2014