Clinical Trials Logo
  1. Home
  2. Rectal Adenocarcinoma
  3. NCT02107105
  4. Details
NCT02107105 Clinical Trial

Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer

Rectal Adenocarcinoma Clinical Trial

Official title:
Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02107105
Other study ID # 2013-0631
Secondary ID NCI-2020-0783520
Status Recruiting
Phase
First received
Last updated
Start date May 16, 2014
Est. completion date May 31, 2025

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact George Chang
Phone 713-792-6940
Email GChang@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.

Description:

PRIMARY OBJECTIVE: I. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years. SECONDARY OBJECTIVES: I. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy. II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer. III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time. OUTLINE: Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment - Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English Exclusion Criteria: - Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer - Patient has a concurrent cancer diagnosis at the time of consent - Patient has recurrent disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Quality-of-Life Assessment
Complete quality of life questionnaire
• Questionnaire Administration
Complete quality of life questionnaire

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Health state utilities A health state utility is the degree of preference that individuals or society has for a particular health state or condition. At 24 months post-surgery
See also
  Status Clinical Trial Phase
Recruiting NCT05081024 - Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Not yet recruiting NCT04090450 - Optimisation of Radiotherapy in Rectal Cancer (ORREC)
Recruiting NCT06050447 - Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Terminated NCT02233595 - Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Completed NCT02935309 - Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma Phase 1
Terminated NCT01887509 - Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology N/A
Recruiting NCT05746195 - Optimization of Adaptive Text Messages for Cancer Survivors (OATS II) N/A
Active, not recruiting NCT03365882 - S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery Phase 2
Completed NCT02314182 - GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis Phase 3
Completed NCT02393755 - Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT04441580 - Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting N/A
Terminated NCT03527784 - Prestoma-Trial for Parastomal Hernia Prevention N/A
Completed NCT00855946 - Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy N/A
Recruiting NCT06328361 - Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer N/A
Terminated NCT03300544 - Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer Phase 1
Active, not recruiting NCT03436563 - M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability Phase 1/Phase 2
Not yet recruiting NCT04814784 - Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum
Recruiting NCT05482516 - Evaluating Novel Therapies in ctDNA Positive GI Cancers Phase 3
Completed NCT02368886 - Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2
Active, not recruiting NCT02688712 - ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer Phase 2

External Links