TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

University of Chinese Academy Sciences

Status: Unknown

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: TOMO; Radiation: IMRT

Study type: Observational

Funder types: Other

Identifiers

NCT03588403

IRB-2018-133

Details and patient eligibility

About

Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
3. Performance status: KPS>70
4. With normal liver function test (ALT, AST <1.5ULN)
5. Renal: creatinine clearance >60ml/min
6. Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
7. Written informed consent

Exclusion criteria

1. WHO type I squamous cell carcinoma or adenocarcinoma

2. Age >65 or <18

3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)

4. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)

5. Patient is pregnant or lactating

6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Trial design

110 participants in 2 patient groups

Arm A:Tomotherapy

Description:

Patients with non-disseminated nasopharyngeal carcinoma receiving Tomotherapy.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.

Treatment:

Radiation: TOMO

Arm B: IMRT

Description:

Patients with non-disseminated nasopharyngeal carcinoma receiving IMRT.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.

Treatment:

Radiation: IMRT