Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy (NPC-GTV)

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 3

Conditions: Nasopharyngeal Carcinoma; Radiotherapy; Induction Chemotherapy

Treatments: Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension

Study type: Interventional

Funder types: Other

Identifiers

NCT04384627

5010-2019-09

Details and patient eligibility

About

To evaluate the long-term locoregional control, survival rate, late toxicity and quality of life after reducing the target volume in patients with locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy.

Full description

This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly-diagnosed locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy. The intervention is delineating the gross tumor volume according to pretreatment tumor extension (the pre-IC GTV group) or post-induction chemotherapy tumor extension (the post-IC GTV group). The objective is to compare the long-term locoregional control, survival rate, late toxicity and quality of life between the two groups.

Enrollment: 445 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologic confirmation of nonkeratinizing nasopharyngeal carcinoma; no previous treatment for cancer; nondistant metastatic, newly diagnosed stage III to IVa disease that was staged according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system; a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); planned to receive 3 cycles of Induction Chemotherapy (regimens included docetaxel and cisplatin; docetaxel, cisplatin, and fluorouracil; and gemcitabine and cisplatin); and adequate hematologic, renal, and hepatic function.

Exclusion criteria

• younger than 18 years or elder than 70 years; receipt of treatment with palliative intent; a history of cancer; receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx or neck; lactation or pregnancy; or severe coexisting illness; had disease progress after IC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

445 participants in 2 patient groups

Pre-IC GTV

Active Comparator group

Description:

The gross tumor volume (GTV) is delineated according to the pretreatment tumor extension

Treatment:

Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension

Post-IC GTV

Experimental group

Description:

The gross tumor volume (GTV) is delineated according to the post-IC tumor extension

Treatment:

Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension