Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT03389295 | Completed Phase 2

• 1 other identifier: TPF-Shanghai
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with locoregionally advanced nasopharyngeal carcinoma

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Reduced Target Delineation and Radiation Doses; Sequential chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 5 years.

  up to 5 years

Secondary Outcomes (9)

• Local recurrence-free survival

  up to 5 years

• Regional recurrence-free survival

  up to 5 years

• Overall survival

  up to 5 years

• Distant metastasis-free survival

  up to 5 years

• Locoregional failure patterns

  up to 5 years

Study Arms (1)

Reduced Target Delineation and Radiation Doses

EXPERIMENTAL

All patients were assigned to receive induction chemotherapy (IC) followed by IMRT with adjuvant chemotherapy (AC). IMRT was administered 2 weeks after IC, and AC was administered 1 month after IMRT. IC or AC (TPF regimen) comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) administered once every 3 weeks for two cycles. During radiotherapy, involved retropharyngeal lymph nodes and intracavity lesions of the primary tumor were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) of the primary tumor were delineated according to the pre-IC volume of the primary tumor as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for delineation. The prescribed dose was 66 Gy to tumors above the slices of skull base or below the orapharynx with less than 5 mm retropharyngeal lymph nodes, or 70.4 Gy to tumors in other slices.

Radiation: Reduced Target Delineation and Radiation Doses

Interventions

Reduced Target Delineation and Radiation Doses RADIATION

The target volumes were delineated according to the treatment protocol defined as follows: the GTV of the primary tumor (GTV-P) included retropharyngeal lymph nodes, considering the common phenomena of integration, and the rest involved lymph nodes that were defined as GTV-N. For the GTV-P, involved retropharyngeal lymph nodes and intracavity lesions were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) were delineated according to the pre-IC volume of the primary lesion as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for GTV-N delineation. The prescribed dose was 66 Gy to tumors above the slices of skull base or below the orapharynx with less than 5 mm retropharyngeal lymph nodes, or 70.4 Gy to tumors in other slices.

Also known as: Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion)

Reduced Target Delineation and Radiation Doses

Eligibility Criteria

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

You may qualify if:

• Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
• Stage Ⅲ-ⅣB disease (AJCC/UICC 2010)
• KPS more than 70
• Life expectancy of more than 6 months
• Signed written informed consent
• Adequate organ function including the following:
• Absolute neutrophil count (ANC) \>= 1.5 \* 109/l Platelets count \>= 100 \* 109/l Hemoglobin \>= 10 g/dl AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) Total bilirubin \<= 1.5 times institutional ULN Creatinine clearance \>= 50 ml/min Serum creatine \<= 1 times ULN

You may not qualify if:

• Evidence of distant metastasis
• Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
• Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
• Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
• Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Sponsors & Collaborators

• Xiayun He, MD: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Xue F, Ou D, Ou X, Zhou X, Hu C, He X. Long-term results of the phase II dose and volume de-escalation trial for locoregionally advanced nasopharyngeal carcinoma. Oral Oncol. 2022 Nov;134:106139. doi: 10.1016/j.oraloncology.2022.106139. Epub 2022 Sep 27.

  PMID: 36179488 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatin; Fluorouracil

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) Radiotherapy：Reduced Target Delineation

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 3, 2018
• Study Start: January 1, 2010
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)