Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan in patients with advanced colorectal cancer.

Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan in patients with advanced colorectal cancer. - Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan in patients with advanced colorectal cancer. (PALODEX-C)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005534

Enrollment

Registered

2011-05-09

Start date

2011-05-01

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

advanced colorectal cancer

Interventions

Group A(Normal Group of Dexamethasone) Day1 Dexamethasone 9.9mg/body (i.v) Palonosetron 0.75mg/body Day2-3 Dexamethasone 8mg/body (p.o) This administration method repeated 4 courses. Group B(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histopathological confirmation of colorectal cancer(Adenocarcinoma) (2) Unresectable or recurrent colorectal cancer (3) No prior chemotherapy (4) Chemotherapy including Oxaliplatin or Irinotecan (5) ECOG performance status of 0,1 (6) Age 20< or = (7) Sufficient organ functions (8) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Severe complications (2) Obstraction of the gastric outlet or bowel (3) Symptomatic brain metastases (4) Massive pleural or abdominal effusion (5) Nervous tic (6) Hypersensitivity or severe drug allergy for 5-HT3RA (7) Hypersensitivity or severe drug allergy for dexamethasone. (8) Serious drug hypersensitivity (9) Emetic episodes or CTCAE grade 2< or = nausea (10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. (11) Any other cases who are regarded as inadequate for study enrollmet by investigators

Design outcomes

Primary

Measure	Time frame
Delayed(24-120hr) complete response rate	—

Secondary

Measure	Time frame
Acute(0-24hr) complete response rate All(0-120hr) complete response rate Acute and delayed and Overall Complete Protection rate Total Control rate No vomiting rate No nausea rate Vomiting episodes Severity of nausea Rescue medication use rate Adverse event	—

Countries

Japan

Contacts

Public ContactTakao Tamura

Nara Hospital Kinki University Faculty of Medicine Department of Medical Oncology

ttamura@nara.med.kindai.ac.jp+81-743-77-0880

Outcome results

None listed

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