GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

Guiyang Medical University

Status and phase: Unknown; Phase 3

Conditions: Locally Advanced Nasopharyngeal Carcinoma

Treatments: Drug: GP+CCRT; Drug: TPF+CCRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03604965

201805043

Details and patient eligibility

About

Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.

2. Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).

3. III, IVa patients (AJCC version 8 staging).

4. Male or non-pregnant women.

5. Age ≥ 18 and < 70 years old.

6. Functional status: Karnofsky scale (KPS) > 70.

7. White blood cells (WBC) ≥ 4 × 109.

   /L, hemoglobin (HGB) ≥ 90 g / L, platelets (PLT) ≥ 100 × 109 / L (or within the normal range of the laboratory)

8. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.

9. Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN.

10. The patient has signed an informed consent form.

Exclusion criteria

1. The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.
2. Age ≥ 70 years old or < 18 years old.
3. Treatment is palliative.
4. Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
5. Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).
6. Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except).
7. Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment).
8. With other serious diseases, it may bring greater risk or affect the compliance of the test. For example: no need for treatment Stable heart disease, kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN),And mental illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

GP+CCRT

Experimental group

Description:

GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

Treatment:

Drug: GP+CCRT

TPF+CCRT

Active Comparator group

Description:

TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

Treatment:

Drug: TPF+CCRT