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De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

NCT04158518 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2019-11-08

No results posted yet for this study

Summary

The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

Toxicities reduced treatment

Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.

RADIATION

Conventional treatment

Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.

Sponsors & Collaborators

  • Chaosu Hu

    lead OTHER

Principal Investigators

  • Chaosu Hu, MD · Fudan University Shanghai Cancer Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158518 on ClinicalTrials.gov