RecruitingPhase 3NCT05527470

Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma


Sponsor

Wei Jiang

Enrollment

440 participants

Start Date

Nov 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved as the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation treatment approaches — intensity-modulated radiation therapy (IMRT) alone versus concurrent chemoradiotherapy — after initial chemotherapy (induction chemotherapy) in people with locally advanced nasopharyngeal carcinoma (cancer at the back of the nose/throat). **You may be eligible if...** - You are 18–65 years old - You have newly diagnosed, histologically confirmed non-keratinizing nasopharyngeal carcinoma - Your cancer is stage III–IVb - You have not received prior chemotherapy or radiation - Your blood counts, liver function, and kidney function are within normal limits - You are in good functional health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has progressed during treatment - You have a life-threatening illness that is not under control - You have previously received radiation or chemotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine,Cisplatin

Induction chemotherapy: Patients receive 1000 mg/m2 gemcitabine intravenously on day 1and day 8, 80mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.

RADIATIONIntensity-modulated radiation therapy (IMRT)

IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were \> 66 Gy to the primary tumor and \> 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.

DRUGCisplatin

Concurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.


Locations(2)

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

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NCT05527470


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