Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

conventional surgery

laparoscopic surgery

P.J. Guillou, MD

RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing conventional surgery is more effective than laparoscopic-assisted surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer.

OBJECTIVES:

* Determine whether longitudinal and circumferential resection margins and lymphatic clearances obtained during laparoscopic surgery are different from those obtained with conventional open surgery in patients with colorectal cancer.
* Compare the patterns of loco-regional or distant metastatic spread after these two surgical methods in these patients.
* Compare the morbidity and mortality rates in these patients after these two surgical methods, particularly in terms of the technical or thromboembolic complications that may develop as a consequence of prolonged pneumoperitoneum.
* Compare the disease-free or overall survival of these patients after these two operative procedures.
* Determine, in those patients in whom laparoscopic surgery fails, which investigatory modalities are appropriate for providing pre-operative indications that a patient is an inappropriate candidate for laparoscopic dissection.
* Compare the differences in quality of life between the two operative procedures, particularly in patients with advanced disease.

OUTLINE: This is a randomized, multicenter study.

Patients undergo laparoscopic surgery or conventional open surgery.

Patients are followed at 1 and 3 months following surgery, then every 3 months for the first year, every 4 months for the second year, and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within 5 years.

Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer

Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer

Medical Research Council

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Recurrence

Lymphoma

Leiomyosarcoma

Lymphosarcoma

Small Intestinal Adenocarcinoma

Small Intestine Cancer

Antineoplastic Agents

Capecitabine

Oxaliplatin

Antimetabolites

capecitabine

oxaliplatin

Eva Szabo, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have colorectal, appendix, or small bowel cancer.

OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of capecitabine when administered with oxaliplatin in patients with colorectal, appendiceal, or small bowel cancer.
* Determine the clinical toxic effects associated with this regimen in these patients.
* Characterize the molecular profile of tumor tissue obtained prior to study entry for determinants of sensitivity to this regimen in this patient population.
* Characterize the molecular profile of a surrogate normal tissue (bone marrow aspirate) obtained prior to treatment and assess any potential drug-associated induction of DNA damage and inhibition of thymidylate synthase with a repeat bone marrow aspirate during therapy.
* Assess any clinical activity of this regimen in this patient population.

OUTLINE: This is a dose-escalation study of capecitabine.

Patients receive oxaliplatin IV over 2 hours on day 1 followed by oral capecitabine twice daily on days 1-5 and 8-12. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 6 months.

PROJECTED ACCRUAL: A total of 106 patients will be accrued for this study within 36 months.

Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal, Appendix, or Small Bowel Cancer

Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients

National Cancer Institute (NCI)

Rectal Neoplasms

Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.

Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.

Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy

5 cm colon-J-pouch with/without temporary protective ileostomy

5 cm colon-J-pouch

side-to-end anastomosis with/without temporary protective ileostomy

side-to-end anastomosis

straight coloanal anastomosis with/without temporary protective ileostomy

straight coloanal anastomosis

Christian T. Hamel, MD

Walter R. Marti, Prof.

Markus Zuber, MD

RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery.

PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.

This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (\> 5 cm vs ≤ 5 cm), age (\< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.

Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer

Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis

Swiss Group for Clinical Cancer Research

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer	NCT00003354	Colorectal Canc...	conventional su... laparoscopic su...	18 Years -	National Cancer Institute (NCI)
Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer	NCT00003354	Colorectal Canc...	conventional su... laparoscopic su...	18 Years -	National Cancer Institute (NCI)
Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal, Appendix, or Small Bowel Cancer	NCT00019773	Carcinoma of th... Colorectal Canc... Small Intestine...	capecitabine oxaliplatin	18 Years -	National Cancer Institute (NCI)
Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer	NCT00238381	Colorectal Canc...	5 cm colon-J-po... side-to-end ana... straight coloan...	18 Years -	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for stage 0 rectal cancer