Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma

NCT07789158 | Not Yet Recruiting Phase 2

• 1 other identifier: ADAPT-02
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether the 2-year local failure-free survival (LRFFS) in Cohort 1 patients with AJCC/UICC 8th edition stage IB-II nasopharyngeal carcinoma who achieved EBV-DNA = 0 after induction chemotherapy and had MRI assessment of complete response (CR) or partial response (PR) ≥50% is non-inferior when treated with reduced-dose IMRT (59.4 Gy/27 fractions) compared to standard-dose IMRT (66.0 Gy/30 fractions).

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

Nasopharyngeal Carcinoma; EBV DNA; MRI; reduced dose radiotherapy; induction chemotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year Locoregional Failure-Free Survival，2-y LRFFS

  The time from enrollment to the first local or regional failure or any cause of death is determined by the event that occurs first. For those who did not experience any of these events, they are censored at the last valid follow-up date.

  2 year

Secondary Outcomes (6)

• 2-year Failure-Free Survival，2-y FFS

  2 year

• 2-year Overall Survival，2-y OS

  2 year

• 2-year Distant Failure-Free Survival，2-y DFFS

  2 year

• Acute Adverse Events，acute AEs

  up to 90 days after radiotherapy

• Late Adverse Events，late AEs

  After 90 days of radiotherapy to the date of death，assessed up to 2 years or more.

Study Arms (3)

Experimental group

EXPERIMENTAL

reduced dose group

Radiation: reduced dose group

Control group

ACTIVE COMPARATOR

standard dose group

Radiation: Standard Dose Group

Corhort 2

OTHER

Other: concurrent chemoradiotherapy

Interventions

reduced dose group RADIATION

59.4 Gy/27F

Experimental group

concurrent chemoradiotherapy OTHER

66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2

Corhort 2

Standard Dose Group RADIATION

66 Gy/30F

Control group

Eligibility Criteria

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

You may qualify if:

• Age: 18 - 65 years old.
• Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing cancer.
• AJCC/UICC 9th edition stage IB-II untreated non-metastatic nasopharyngeal carcinoma (T3 requires no extensive cranial base invasion and the invasion volume should be \< 22 mL; N1-2 requires baseline lymph nodes \< 4 cm).
• Before treatment, plasma EBV-DNA needs to be tested and dynamic monitoring of EBV-DNA can be completed.
• ECOG performance status 0 - 1 points.
• Main organ functions meet the following requirements: neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; creatinine clearance rate ≥ 60 mL/min.
• Sign a written informed consent form and be willing to complete the treatment, follow-up and quality of life assessment according to the protocol.

You may not qualify if:

• Metastasis to T4, N3 or distant sites; AJCC/UICC 9th edition stage III-IV.
• Had received chemotherapy, targeted therapy, or immunotherapy before the diagnosis of nasopharyngeal carcinoma, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
• Pregnant or lactating; non-pregnant and non-lactating subjects who do not agree to take effective contraceptive measures.
• Had severe and uncontrollable heart, lung, liver, kidney, neurological or mental diseases, and the investigator judged that they were not suitable for radical treatment or affected compliance.
• Had a history of other malignant tumors within the past 5 years, except for the following situations: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.
• Could not complete the imaging examinations, EBV-DNA tests, follow-up or quality of life assessment as required by the protocol.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Population Groups; Chemoradiotherapy

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)

Demography; Population Characteristics; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Xiayun He

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiayun He, MD

CONTACT

+86021-64175590-81412; hexiayun1962@163.com

Fen Xue, MD

CONTACT

+8618916882304; dr_fenxue@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)