Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Colorectal cancer (CRC) is a significant and growing health burden in Hong Kong. According to data from Hong Kong Cancer Registry, CRC ranked the first in incidence and the second in mortality, with around 5,000 new cases diagnosed and more than 2,000 cancer-related mortality in 2014. The investigators aim to evaluate the association between serial weight change during first line treatment and outcomes in patients with metastatic CRC.
Studies have suggested that exposure to a greater number of chemotherapeutic agents is associated with better survival in metastatic colorectal cancer.
Multiple factors might affect body weight during treatment. Cancer-related symptoms can impair quality of life and appetite. Cachexia syndrome affects around 50% of colon cancer patients and is characterized by cancer-induced catabolism with involuntary weight loss (fat and muscle), patients have increased lipolysis and change in skeletal muscle metabolism, including increased energy expenditure at rest and protein degradation, and decreased protein synthesis. Besides these disease factors, treatment related side effects are common causes of weight loss, such as inability to ingest or digest food effectively due to nausea, vomiting, and malaise. Based on these factors and the hypotheses between tumour control and weight gain, monitoring the serial weight change can have practical value.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stage IV colorectal cancer | stage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| first line systemic treatment for colorectal cancer | Drug | systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Survival time from start of anti-cancer treatment until disease progression, or death from disease, or loss of follow-up | From date of start of anti-cancer treatment until the date of first documented progression (assessed by physical examination, imaging, or blood biomarkers) or date of death from any cause, whichever came first, assessed up to 60 months |
| Overall survival | Survival time from start of anti-cancer treatment until death from any cause, or loss of follow-up | From date of start of anti-cancer treatment until the date of death from any cause (assessed by physical examination, imaging, or blood biomarkers), assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy dose change | Chemotherapy dose change (in percentage change) | from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months |
| Chemotherapy interruption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Single institutional cohort of stage IV (advanced) colorectal cancer patients who undergo systemic treatments.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shing Fung Lee, MBBS, M Sc | Contact | 85224685087 | leesfm@ha.org.hk | |
| King Fung Tsang, M Sc | Contact | 85224685769 | tkf179@ha.org.hk |
| Name | Affiliation | Role |
|---|---|---|
| Shing Fung Lee, MBBS, M Sc | Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun | Recruiting | Hong Kong | Hong Kong |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2019 | Jan 14, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D015431 | Weight Loss |
| D009369 | Neoplasms |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Chemotherapy dose interruption (in percentage change)
| from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001836 | Body Weight Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |