Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02107105

Conditions

Rectal Adenocarcinoma

Stage I Rectal Cancer AJCC v8

Stage II Rectal Cancer AJCC v8

Stage IIA Rectal Cancer AJCC v8

Stage IIB Rectal Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief 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.

Conditions

Rectal Adenocarcinoma

Stage I Rectal Cancer AJCC v8

Stage II Rectal Cancer AJCC v8

Stage IIA Rectal Cancer AJCC v8

Stage IIB Rectal Cancer AJCC v8

Study ID

NCT02107105

Start date

May 16, 2014

Status verified date

Aug, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

430 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (questionnaire)

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.

Interventions

Quality-of-Life Assessment

Complete quality of life questionnaire

Questionnaire Administration

Complete quality of life questionnaire

Primary outcome measure

  • Health state utilities [ Time Frame: At 24 months post-surgery ]

Central Contacts and Locations

Central contacts

George Chang

713-792-6940GChang@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

George J. Chang

713-792-6940

Principal Investigator:

George J. Chang

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-31.