Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma

NCT05994170 | Recruiting DMC

• 1 other identifier: ZSCPH-002
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.

Conditions

Nasopharyngeal Carcinoma; Intensity-Modulated Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Local Relapse-free Survival(LRFS)

  the time from randomization to documented local recurrence or death from any cause

  3 years

• Incidence of hearing impairment worse than graded 2

  audiometry and symptoms graded according to the CTCAE (version 5.0).

  3 years

Secondary Outcomes (9)

• Overall survival (OS)

  3 years

• Regional Relapse-free Survival(RRFS)

  3 years

• Distant metastasis-free survival (DMFS)

  3 years

• Acute toxicities

  3 months

• Late toxicities

  3 years

Study Arms (2)

Reduction CTVp1

EXPERIMENTAL

CTVp1=GTVp+5mm

Radiation: Reduction CTVp1

Non-reduction CTVp1

PLACEBO COMPARATOR

CTVp1=GTVp+5mm+whole nasopharynx

Radiation: Non-reduction CTVp1

Interventions

Reduction CTVp1 RADIATION

High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)

Reduction CTVp1

Non-reduction CTVp1 RADIATION

High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)

Non-reduction CTVp1

Eligibility Criteria

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

You may qualify if:

• histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
• newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
• nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
• planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA\>4000 copies，node \>3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
• no previous treatment for cancer；
• a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
• between 18 and 70 years old;
• adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

• receipt of treatment with palliative intent;
• receipt of previous treatment (radiotherapy, chemotherapy, or surgery \[except diagnostic procedures\]) to the nasopharynx;
• had disease progress after neoadjuvant chemotherapy in local advantage NPC
• presence of distant metastasis;
• Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
• Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
• Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
• lactation or pregnancy;
• Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead
• Sun Yat-sen University Cancer Centre: collaborator

Study Sites (1)

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

MeSH Terms

Conditions

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

• Gui-qiong Xu

  Zhongshan People's Hospital, Guangdong, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gui-qiong Xu

CONTACT

+8613528109888; donna_shee@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 16, 2023
• Study Start: August 4, 2023
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

CN (1)