Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer

Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer - Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer:QUACK trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010985

Enrollment

140

Registered

2013-06-19

Start date

2013-06-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable colorectal cancer

Interventions

QoL assessment for the patient treated with 1st line cetuximab containing regimen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients(pts) with advanced colorectal cancer (CRC) planned to be treated with a cetuximab containing regimen 2. EGFR positive CRC 3. Not decided KRAS mutated within codon 12 or 13 CRC 4. Pts with evaluable disease 5. No prior chemotherapy for advanced CRC 6. ECOG PS 0 to 2 7. Preserved organ function 8. Life expectancy of more than 3 months 9. HBsAg negative 10. Agreement of contraception 11. Written informed consent 12. Ability to answer to the QoL questionnaires

Exclusion criteria

Exclusion criteria: 1. Serious bone marrow suppression 2. Serious sensory disturbance 3. History of mental disturbance of cerebrovascular attack 4. Irradiation for evaluable disease 5. Severe stenosis of primary site 6. Serious drug hypersensitivity or a history of allergic reaction from drugs 7. Uncontrolled hypertension, diabetes, or hypercalcemia 8. Liver cirrhosis, hepatic failure or renal failure 9. Interstitial lung disease, pulmonary fibrosis or pulmonary emphysema. 10. Active infection 11. Heart insufficiency or history of heart insufficiency 12. Brain metastases 13. Massive pleural effusion, ascites or pericardial effusion. 14. Watery diarrhea 15. Active concomitant malignancy 16. Pregnant woman, possibility pregnant woman, or nursing woman 17. Patients considered ineligible for the trial

Design outcomes

Primary

Measure	Time frame
1. correlation between skin toxicity +/- other adverse events and QoL 2. correlation between efficacy and skin toxicity 3. correlation between efficacy and QoL 4. concordance between DLQI and EORTC QLQ-C30	—

Countries

Japan

Contacts

Public ContactAkira Ooki

Saitama Cancer Center Department of Gastroenterology

sp9y9tq9@piano.ocn.ne.jp048-722-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026