Recurrent Rectal Cancer Clinical Trial
Official title:
Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for
rectal cancer and may have fewer side effects and improve recovery. It is not yet known
whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in
treating patients with rectal cancer.
PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see
how well it works compared to laparoscopic surgery in treating patients with rectal cancer
that can be removed by surgery.
OBJECTIVES:
I. To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal
cancer resection by means of a randomized, controlled trial.
II. To assess technical ease of the operation, as determined by the clinical indicator of
low conversion rate to open operation.
III. To assess surgical accuracy and improved oncological outcome as determined by clear
pathological resection margins.
IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge
to inform NHS and other service providers and decision-makers.
V. To analyze disease-free and overall survival and local recurrence rates at 3-year
follow-up.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard laparoscopic resection.
ARM II: Patients undergo robotic-assisted laparoscopic resection.
After completion of study treatment, patients are followed up at 1 month, 6 months, and then
annually thereafter for 3 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01987726 -
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
|
||
| Active, not recruiting |
NCT00826540 -
Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| 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 | |
| Recruiting |
NCT04642924 -
SGM-101 in Locally Advanced and Recurrent Rectal Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
| Completed |
NCT01217450 -
Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT01191684 -
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
|
Phase 1 | |
| Terminated |
NCT01238965 -
Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy
|
Phase 1 | |
| Terminated |
NCT01285102 -
Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer
|
Phase 1 | |
| Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
| Completed |
NCT00551421 -
Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00407654 -
VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT00091182 -
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
|
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 | |
| Not yet recruiting |
NCT05076305 -
PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
|
||
| Completed |
NCT01740648 -
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer
|
Phase 1 | |
| 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 |