Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Reduce Treatment Intensity; Induction Chemotheray; Stage II, III; Nasopharyngeal Squamous Cell Carcinoma; Concurrent Chemoradiotherapy

Treatments: Drug: Docetaxel; Radiation: IMRT; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03908372

NCC1950

Details and patient eligibility

About

The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.

Full description

The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed.

The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pathology confirmed nasopharyngeal squamous cell carcinoma.
• Aged 18 to 70 years old;
• Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm;
• KPS≥70;
• Have measurable lesions on CT/MRI before treatment;
• Treatment for the first time;
• At least 6 months lifetime was expected;
• Adequate laboratory indexes, defined as follows: Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L < 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss;
• Can understand and sign the consent
• Have follow up condition

Exclusion criteria

• Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
• Previously treatment for cancer
• Pregnant or breeding woman, female without contraception
• Enrolling in other drug trials
• Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
• Without follow up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Induction chemotherapy(IC)+IMRT

Experimental group

Description:

Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm

Treatment:

Drug: Cisplatin

Radiation: IMRT

Drug: Docetaxel

Concurrent chemoradiotherapy(CCRT)

Active Comparator group

Description:

cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy

Treatment:

Drug: Cisplatin

Radiation: IMRT