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Health Related Quality of Life in Patients with Colorectal Liver Metastasis Undergoing Liver Surgery

Trial Status: Active

This research trial studies the health related quality of life in patients with colorectal cancer that has spread to the liver (metastatic) who are undergoing liver surgery. Collecting information from quality of life questionnaires from patients before and after liver surgery may help doctors understand the long-term effects that cancer treatments have on patients and may help patients to make better decisions about their treatment options and know what to expect after surgery.

Inclusion Criteria

  • Diagnosis of colorectal cancer liver metastases (CRLM)
  • Absence of unresectable extrahepatic disease
  • No previous liver surgery for CRLM
  • Clinical risk score (CRS) >= 3 or > 4 tumors * CRS includes the following variables: ** Lymph node positive primary ** Disease free interval < 12 months ** CEA level > 200 ng/ml (highest CEA level within 6 months prior to surgery, not including day of surgery) ** Tumor size > 5 cm ** Number of tumors > 1 (based on most recent scan or pathology before liver resection) * Each variable is give a score of one and summed to give final CRS
  • Clinical risk score (CRS) < 3 with pending variables that cannot be determined preoperatively * If CRS is still < 3 postoperatively, these patients will be excluded and replaced (inevaluable)
  • Ability to read and write in English
  • Undergoing liver resection/ablation for CRLM
  • Underwent liver resection/ablation for CRLM, but not their primary tumors

Exclusion Criteria

  • Non-English speaking
  • Inability to read and/or write
  • International patients
  • Concurrent malignancy (excluding non-melanoma skin cancers)

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Michael D'Angelica
Phone: 212-639-3266
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Michael D'Angelica
Phone: 212-639-3226
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Michael D'Angelica
Phone: 212-639-3226

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Michael D'Angelica
Phone: 212-639-3226
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Michael D'Angelica
Phone: 212-639-3266
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Michael D'Angelica
Phone: 212-639-3226
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Michael D'Angelica
Phone: 212-639-3226

PRIMARY OBJECTIVE:

I. To assess health related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), Quality of Life Questionnaire Liver Metastases Colorectal 21 (QLQ-LMC21) and the European Quality of Life (EuroQoL) Five Dimension Five Level Scale (EQ-5D-5L)/visual analogue scale (VAS), in patients at high risk of recurrence undergoing hepatectomy for colorectal cancer liver metastasis (CRLM) and to evaluate global and disease specific changes over time.

SECONDARY OBJECTIVE:

I. To explore how HRQoL scores are impacted as patients transition through different stages in the course of disease and treatment during follow up, including: disease free off treatment, recurrent disease salvageable with surgery, recurrent disease not salvageable with surgery, persistent disease on long term non-curative therapies, and/or best supportive care.

OUTLINE:

Patients complete quality of life questionnaires at baseline, at the first postoperative clinic visit, and at 6, 12, 18, 24, and 36 months after hepatectomy.

Trial Phase Phase NA

Trial Type Ancillary-correlative

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Michael D'Angelica

  • Primary ID 15-057
  • Secondary IDs NCI-2016-01693
  • Clinicaltrials.gov ID NCT02399995