The phase I study to determine MTD of three-week lobaplatin with concurrent Radiation Therapy for locally advanced nasopharyngeal carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONRC-12002392

Enrollment

Unknown

Registered

2012-07-24

Start date

2012-07-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

nasopharyngeal carcinoma

Interventions

One group:MTD of three-week lobaplatin with concurrent Radiation Therapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years old; male or female patients; 2. With the diagnosis of nasopharyngeal carcinoma confirmed by pathological or cytology tests except pure bronchioloalveolar carcinoma; 3. The phase of III or IVa locally advanced nasopharyngeal carcinoma patients; 4. The first-line therapy, The patients did not receive any chemotherapy and radiation Therapy; 5. With measurable metastasis foci; 6. Without massive metastasis confirmed by MRI\CT and so on; 7. Weight loss is less than 10% during recently 6 monthes and could tolerate radiation Therapy; 8. ECOG PS: 0 or 1; 9. Life expectancy >=3 months; 10. Laboratory parameters: Bone marrow function: ANC>=1.5*10^9/L; PLT>=80*10^9/L; HB>=90g/L; Hepatic function: STB and CB=60 ml/min (Cockcroft-Gault); Coagulation function:PT INR) <=ULN*1.5; 11. Female: postmenopausal period or have received sterilization operation, or contraception during treatment and within 6 months after the therapy; non-breast feeding period; Male: have received sterilization operation, or contraception during treatment and within 6 months after the therapy; 12. Voluntary to participate and sign informed consent document.

Exclusion criteria

Exclusion criteria: 1. Allergic to platinum drugs used in the trial; 2. Have received surgical intervention within the latest 3 weeks; 3. Have the malignant tumor of other tissue within 5 years (excluding cerical cancer, basal cell carcinoma or squamous carcinoma); 4. Severe cardiaovascular diseases including uncontrolled hypertension, unstable angina pectoris, cardiac infarction, heart failure (>2 according to NYHA standard) and severe cardiac arrhythmia; 5. Patients needing anticoagulation therapy or vitamin K antagonists (excluding prevention use of small dosage of warfarin<=1mg/d and aspirin<=100mg/d); 6. Have participated in other drug trial within the latest 4 weeks; 7. The patients with mental disease have the poor compliance; 8. Other patients that are not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
DLT;	—

Countries

China

Contacts

Public ContactHoujie Liang

lianghoujie@sina.com023-68754128

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026