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

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

surgical resection and adjuvant therapy

Neoadjuvant followed by operation

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring local recurrent rectal cancer, surgical resection, adjuvant therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Gastrointestinal Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgical resection and adjuvant therapy

Neoadjuvant followed by operation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

5-year disease free survival

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

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

Full Information

NCT ID

NCT01271192

First Posted

January 5, 2011

Last Updated

January 5, 2011

Sponsor

Sun Yat-sen University

Collaborators

Guangdong Provincial People's Hospital, Second Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01271192

Brief Title

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

Acronym

NARC

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Sun Yat-sen University

Collaborators

Guangdong Provincial People's Hospital, Second Military Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Rectal Cancer

Keywords

local recurrent rectal cancer, surgical resection, adjuvant therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgical resection and adjuvant therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Neoadjuvant followed by operation

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

surgical resection and adjuvant therapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Neoadjuvant followed by operation

Intervention Description

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

Primary Outcome Measure Information:

Title

5-year disease free survival

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate,biomarkers, quality of life, toxic profile, convenience

Description

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Adenocarcinoma of the rectum Age:18-80 years old Received curative resection when diagnosed as rectal cancer Local recurrence happened >6 months after operation,without distant metastasis 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: Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma) Synchronous colon cancer Hypersensitivity to fluorouracil No More than 4 weeks since prior participation in any investigational drug study Clear indication of involvement of the pelvic side walls by imaging With distant metastasis History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception Uncontrolled hypertension Cardiovascular disease that would preclude study treatment or follow-up Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding Pregnant or nursing, Fertile patients do not use effective contraception 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 No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ping Lan, M.D.

Phone

008613710316769

lpzm@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping Lan, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Director

Facility Information:

Facility Name

Gastrointestinal Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pang Lan, M.D.

Phone

008613710316769

lpzm@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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