Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517135
• Other study ID #: 2022/2315
• Status: Recruiting
• Start date: November 17, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2023
• Source: National Cancer Centre, Singapore
• Contact: Melvin Lee Kiang Chua, MBBS, FRCR, PhD, FAMS
• Phone: 64368000
• Email: melvin.chua.l.k[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective platform study that will investigate the outcomes of patients with locoregionally-advanced nasopharyngeal carcinoma (LA-NPC) or recurrent-metastatic nasopharyngeal carcinoma (RM-NPC) who are assigned to treatment arms of different chemotherapy sequencing and intensity based on their pre- and on-treatment plasma EBV DNA results.

Description:

The primary objectives of this platform are: (1) to prospectively validate the prognostic potential of an EBV DNA-based risk-stratification strategy of patients with LA- and RM-NPC; and (2) to test if treatment individualization strategies based on pre- and on-treatment plasma EBV DNA will improve survival outcomes. Primary study end-point is 2-year disease-free survival (DFS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

Any patients =21 years of age with any of the following:

1. Suspected NPC cases, diagnosed clinically based on symptoms (neck swelling, unilateral epistaxis, nasal obstruction etc.)

2. Newly-diagnosed, histologically confirmed NPC patients with Stages 2-4A disease based on the AJCC/UICC 8th Edition TNM stage classification

3. Newly-diagnosed patients with RM-NPC

Exclusion Criteria:

All patients <21 years or >99 years old will be excluded from participation.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Other:
• Arm 1
Concurrent chemoradiotherapy (CCRT) using cisplatin (100 mg/m2 IV) or carboplatin (AUC 5 IV) with radiotherapy +/- adjuvant chemotherapy (AC) with capecitabine (physician's choice of 650 mg/m2 bid or 1000 mg/m2 bid oral, d1-21, q3w)
• Arm 2
IC using cisplatin (80 mg/m2 IV) or carboplatin (AUC 3-5 IV) in combination with gemcitabine (1000 mg/m2 d1,8) or 5-fluorouracil (1000 mg/m2 bolus IV d1-4) or docetaxel (75 mg/m2 IV), and CCRT
• Arm 3
CCRT + metronomic capecitabine (650 mg/m2 bid oral, d1-21, q3w)
• Group 1
Combination chemotherapy (using cisplatin or carboplatin with gemcitabine, 5-fluorouracil or docetaxel) and consolidative RT to the nasopharynx and neck (if good response to chemotherapy) +/- metastasis-directed therapy (surgery, radiofrequency ablation or RT) +/- immune checkpoint blockade (ICB) or capecitabine
• Group 2
Combination chemotherapy (using cisplatin or carboplatin with gemcitabine, 5-fluorouracil or docetaxel) with or without ICB +/- maintenance ICB or capecitabine

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival		2 years from end of treatment
Secondary	Overall survival		2 years after end of treatment
Secondary	Distant metastasis-free survival		2 years after end of treatment
Secondary	Loco-regional recurrence-free survival		2 years after end of treatment
Secondary	Treatment-related adverse events		From start of treatment to 30 days after last treatment and up to 5 years post - treatment
Secondary	Genome sequencing of biological samples	Blood samples will be collected at up to 7 timepoints - baseline, mid/post IC, mid CCRT, 1-2 weeks post-RT, 3 months post-RT/mid-adjuvant chemotherapy, at point of recurrence and post immune checkpoint blockade treatment (for recurrence, if any); fresh biopsy samples will be collected at baseline and at point of recurrence, if amenable for biopsy. Saliva samples will be collected at baseline and at point of recurrence.	baseline, mid/post IC, mid CCRT, 1-2 weeks post-RT, 3 months post-RT/mid-adjuvant chemotherapy, at point of recurrence and post immune checkpoint blockade treatment (for recurrence, if any) up to 5 years