phase II trial of the FOLFOX regimen as 1st line treatment in adenocarcinoma of unknown primary

Single-arm phase II trial of the combination chemotherapy of 5-fluorouracil, Folinic acid, and oxaliplatin as 1st line treatment in adenocarcinoma of unknown primary

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000410

Enrollment

Registered

2012-04-23

Start date

2009-11-04

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Modified FOLFOX6 q 2weeks Oxaliplatin 100 mg/m2 iv for 2hours, D1 5-FU 400 mg/m2 iv bolus, D1 5-FU 2,400 mg/m2 civ for 46 hours, D1 Leucovorin 200mg/m2 iv for 2 hours, D1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newly diagnosed adenocarcinoma of unknown primary origin (histologic diagnosis) Tests described below to find out the origin or cancer should be performed.' complete blood count, chemistry, urine analysis chest & abdomen-pelvis enhanced CT Mammography in case of female patient (Breast MRI if clincally suspected breast cancer) Endoscopy (Stomach, colon) Other nessesary tests about the suspected primary Exclusion of suspected origin through review of histopathologic findings as follows: Estrogen or progesterone receptor positive in female patients TTF (Thyroid transcription factor 1) positive PSA (Prostate specific antigen) positive in male patients Age: over 20 years old

Exclusion criteria

Exclusion criteria: Axillary lymph node metastasis in female patient papillary adenocarcinoma of abdominal cavity in female patient bone adenocarcinoma with elevating PSA in male patient Potentially resectable metastatic cancer Brain metastasis History of surgery of malignant tumor cancer other than adenocarcinoma (ex. leiomyosarcoma, lymphoma) or secondary malignancy. (basal cell skin cacner or uterine cervix intraepithelial cell carcinoma that were previously successfully treated were exceptions)

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
overall response rate;overall survival	—

Countries

Korea, Republic of

Contacts

Public ContactDong-Yeop Shin

Korea Cancer Center Hospital

Outcome results