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

NCT ID: NCT05994170

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 454 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2029-09-01

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.

Detailed Description

This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.

Conditions

Nasopharyngeal Carcinoma; Intensity-Modulated Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Reduction CTVp1

CTVp1=GTVp+5mm

Group Type: EXPERIMENTAL

Reduction CTVp1

Intervention Type: 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)

Non-reduction CTVp1

CTVp1=GTVp+5mm+whole nasopharynx

Group Type: PLACEBO_COMPARATOR

Non-reduction CTVp1

Intervention Type: 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)

Interventions

Reduction CTVp1

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

Intervention Type: RADIATION

Non-reduction CTVp1

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)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);

2. newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system

3. 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.

4. 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 )

5. no previous treatment for cancer；

6. a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);

7. between 18 and 70 years old;

8. 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);

9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria

1. receipt of treatment with palliative intent;

2. receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx;

3. had disease progress after neoadjuvant chemotherapy in local advantage NPC

4. presence of distant metastasis;

5. Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;

6. Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;

7. Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;

8. lactation or pregnancy;

9. Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University Cancer Centre

UNKNOWN

Sponsor Role: collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role: lead

Responsible Party

Gui-Qiong Xu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gui-qiong Xu

Role: PRINCIPAL_INVESTIGATOR

Zhongshan People's Hospital, Guangdong, China

Locations

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gui-qiong Xu

Role: CONTACT

donna_shee@163.com

+8613528109888

Facility Contacts

Guiqiong Xu

Role: primary

donna_shee@163.com

+8613528109888

Yu-long Xie, MD

Role: backup

xieyl1@sysucc.org.cn

+8615625031643

Other Identifiers

ZSCPH-002

Identifier Type: -

Identifier Source: org_study_id