Endostar for Locally Recurrent Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Endostatins; Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02636231

NPC201501

Details and patient eligibility

About

The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Full description

Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.

The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
2. No evidence of distant metastasis
3. More than 1 year from the end of the first course of radiotherapy
4. Male, or female not in the phase of lactating or pregnancy
5. ECOG 0-2
6. Aged 18-70 years old
7. WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
8. Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
9. Written informed consort signed

Exclusion criteria

1. Only regionally recurrence
2. Evidence of distant metastasis
3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
4. Severe, active co-morbidity
5. Prior anti-tumor treatment after diagnosis of local recurrence
6. MRI was not performed 3 months after the first course of radiotherapy
7. Abnormal function of heart, brain and lungs, etc
8. Lactation or pregnancy
9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

IMRT and concurrent Endostar

Active Comparator group

Description:

IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. IMRT is to give GTV 60Gy in 27 fractions.

Treatment:

Radiation: IMRT

Drug: Endostatins

IMRT alone

Experimental group

Description:

IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.

Treatment:

Radiation: IMRT