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

NCT01271192 | Unknown DMC

• 1 other identifier: GIHSYSU02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

local recurrent rectal cancer; surgical resection; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (2)

Surgical resection and adjuvant therapy

ACTIVE COMPARATOR

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

Neoadjuvant followed by operation

EXPERIMENTAL

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

Interventions

surgical resection and adjuvant therapy PROCEDURE

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

Surgical resection and adjuvant therapy

Neoadjuvant followed by operation PROCEDURE

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

Neoadjuvant followed by operation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangdong Provincial People's Hospital: collaborator
• Second Military Medical University: collaborator

Study Sites (1)

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ping Lan, M.D.

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Ping Lan, M.D.

CONTACT

008613710316769; lpzm@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2020
• Last Updated: January 6, 2011

Record last verified: 2010-12

Locations

CN (1)