Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00303628
Other study ID # E5204
Secondary ID NCI-2009-00563CD
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 11, 2006
Est. completion date February 11, 2019

Study information

Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.


Description:

Read more »
Read more »

Study Design


Intervention

Drug:
oxaliplatin
Given IV
fluorouracil
Given IV
leucovorin calcium
Given IV
bevacizumab
Given IV

See more »

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Peru,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Rectal Function Between Baseline and 12 Months Change in rectal function between baseline and 12 months was measuring the long-term rectal function among the patients. Rectal function was measured using the Bowel Function Questionnaire at baseline and 12 months after randomization. The total score of the questionnaire was calculated as the number of problems with bowel function (score range 0-11). Change in rectal function between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated improved rectal function. This change in score was calculated for each individual patient who had the data. assessed at baseline and 12 months after randomization
Other Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months Change in oxaliplatin-related neurotoxicity between baseline and 12 months was measuring the long-term symptom of oxaliplatin-related neurotoxicity among the patients. Oxaliplatin-related neurotoxicity was measured using the FACT/GOG-Ntx subscale at baseline and 12 months after randomization. The range of the total score of the scale was between 0 and 44, and lower values indicate higher neurotoxicity. Change in oxaliplatin-related neurotoxicity between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated worsened symptom. This change in score was calculated for each individual patient who had the data. assessed at baseline and 12 months after randomization
Primary 5-year Overall Survival Rate Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate. Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization
Secondary 5-year Disease-free Survival Rate Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer or death, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Kaplan-Meier method was used to estimate 5-year DFS rate. Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization
Secondary Patterns of Failure Failure included recurrence, second primary cancer and death without recurrence. Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization
Secondary Proportion of Patients Who Completed 12 Cycles of Treatment In the study, treatment was repeated every 2 weeks for a total of 12 cycles on both arms. The total number of cycles of treatment patient received until going off treatment due to any reason was recorded. It was a measure of the tolerance of the therapy. assessed at the end of treatment
See also
  Status Clinical Trial Phase
Completed NCT00025337 - Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Phase 3
Completed NCT03871959 - Pembrolizumab In Combination With Debio 1143 In Pancreatic and Colorectal Advanced/Metastatic Adenocarcinoma Phase 1
Recruiting NCT05080673 - Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps N/A
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2
Completed NCT00707889 - Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer Phase 2
Completed NCT00551421 - Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer Phase 1/Phase 2
Terminated NCT00052585 - Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer Phase 2
Completed NCT00023933 - Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer Phase 1
Recruiting NCT03303547 - Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits N/A
Active, not recruiting NCT01037049 - Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks Phase 2
Terminated NCT00397878 - AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer Phase 2
Completed NCT00100841 - Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer Phase 2
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Recruiting NCT04005118 - Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery
Completed NCT02641691 - Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum Phase 2
Completed NCT00307736 - Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer Phase 1/Phase 2
Completed NCT00003799 - Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer Phase 1
Terminated NCT02425683 - Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX Phase 2
Recruiting NCT05669430 - A Study of GV20-0251 in Patients With Solid Tumor Malignancies Phase 1
Completed NCT01340755 - Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer N/A