Dose Constraints for the Temporal Lobes of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma

NCT03539250 | Unknown

• 1 other identifier: zl2017
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however, there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with IMRT. Knowledge of the dose tolerance of the TL is essential, in order to predict the safety of intensity-modulated radiotherapy (IMRT) treatment plans. In our previous studies, D1cc (the dose to 1ml of the TL volume) and Dmax (the maximum point dose) were the significant predictors of TLI development. The purpose of this study is to evaluate the feasibility of dose constraints based on D1cc and Dmax for the temporal lobes following IMRT for NPC.

Conditions

Injury; Temporal Region

Keywords

Radiation-induced temporal lobe injury;NPC; Nasopharyngeal carcinoma; Intensity-modulated radiotherapy

Outcome Measures

Primary Outcomes (1)

• The incidence of radiation-induced temporal lobe injury at 5 years

  The incidence of radiation-induced temporal lobe injury at 5 years will be calculated

  5 years

Secondary Outcomes (1)

• Local recurrence-free survival at 5 years

  5 years

Study Arms (1)

IMRT with and without chemotherapy

EXPERIMENTAL

Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).

Radiation: IMRT

Interventions

IMRT RADIATION

IMRT with and without chemotherapy

IMRT with and without chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly-diagnosed and confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III, Stage I-IVA (AJCC staging, 2017, 8th edition), treated with intensity-modulated radiotherapy.
• No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
• Age between 18 years and 70 years.
• Karnofsky score ≥80
• WBC≥ 4,000/ul, platelets≥ 100,000/ul; serum creatinine≤ 1.6 mg/dl or 24hr. calculated creatinine clearance ≥ 60ml/min.
• Must undergo pre-treatment evaluation of tumor extent and tumor measurement. Tumor may be measurable or evaluable.
• Signed study-specific consent form prior to study entry.

You may not qualify if:

• Stage IVB
• Evidence of distant metastases
• Previous irradiation for head and neck tumor ≤ 6 months prior to study entry
• Previous chemotherapy ≤ 6 months prior to study entry
• Patient is on other experimental therapeutic cancer treatment
• Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years
• Active untreated infection
• Major medical or psychiatric illness, which in the investigator's opinions, would interfere with either the completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy
• Pregnant women

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator

MeSH Terms

Conditions

Wounds and Injuries; Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jin-Gao Li, MD

  Jiangxi cancer hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zeng, MD

CONTACT

(86)0791-88314495; zlsports100@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of Science and Euducation Division

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: May 29, 2018
• Study Start: June 10, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2025
• Last Updated: May 29, 2018

Record last verified: 2018-05