Nasopharyngeal Carcinoma (NPC)Phase 2NCT07789158
Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma
A Phase 2 study testing reduced dose group, Standard Dose Group and concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- reduced dose group, Standard Dose Group and concurrent chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiayun He, MD, +86021-64175590-81412, hexiayun1962@163.com
Fen Xue, MD, dr_fenxue@163.com
About this study
Official title: Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma: A Prospective Single-center Randomized Phase II Study
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).
Read the detailed description
This study focused on patients with AJCC/UICC 9th edition stage IB-II（The participants were required to have no extensive skull base invasion and lymph nodes < 4 cm before treatment）. It aimed to adaptively guide the reduction of radiation dose for nasopharyngeal carcinoma based on the response to induction chemotherapy, thereby minimizing radiation-related toxicity while ensuring local control. Cohort 1 was randomly assigned 1:1 to the 59.4 Gy/27 fractions group and the 66.0 Gy/30 fractions group and compared their LRFFS. The participants were required to have EBV-DNA = 0 and CR or PR > 50% after 2 courses of induction therapy. Those who did not meet the criteria were assigned to Cohort 2 to receive standard-dose radiotherapy combined with concurrent cisplatin to avoid excessive reduction of intensity for potentially high-risk patients.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- reduced dose group, Standard Dose Group, concurrent chemoradiotherapy
- Keywords
- Nasopharyngeal Carcinoma, EBV DNA, MRI, reduced dose radiotherapy, induction chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced dose groupRadiation
59.4 Gy/27F
Standard Dose GroupRadiation
66 Gy/30F
concurrent chemoradiotherapyOther
66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | reduced dose group Receives: Radiation: reduced dose group |
| Control group | Active comparator | standard dose group Receives: Radiation: Standard Dose Group |
| Corhort 2 | Other | Not described Receives: Other: concurrent chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Secondary outcomes (6)
2-year Failure-Free Survival，2-y FFS
The time from enrollment to the first occurrence of local regional failure, distant metastasis, or death due to any cause is determined by the event that occurs first.
Measured: 2 year
2-year Overall Survival，2-y OS
The time from enrollment to any cause of death; for those who were still alive at the end of the follow-up, the data are censored at the date of the last confirmed survival.
Measured: 2 year
2-year Distant Failure-Free Survival，2-y DFFS
The time from enrollment to the first distant metastasis or any cause of death is determined by the event that occurs first.
Measured: 2 year
Acute Adverse Events，acute AEs
The evaluation was conducted according to NCI-CTCAE v5.0 from the start of radiotherapy to 90 days after radiotherapy.
Measured: up to 90 days after radiotherapy
Late Adverse Events，late AEs
After 90 days of radiotherapy, the evaluation was conducted according to CTCAE v5.0 and RTOG/EORTC standards for late radiation injury.
Measured: After 90 days of radiotherapy to the date of death，assessed up to 2 years or more.
Quality of Life，QoL (EORTC QLQ-H&N35）
Changes in QoL of participants from baseline to up to 6 months after the completion of radiotherapy. QoL will be evaluated with the questionnaires of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30). Higher scores mean a worse outcome.
Measured: baseline and up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
- Investigators
- Xiayun He, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789158
- Sponsor's protocol ID
- ADAPT-02
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma: A Prospective Single-center Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT07789158
- Acronym / sponsor ID
- ADAPT-02
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma, EBV DNA, MRI, reduced dose radiotherapy, induction chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study focused on patients with AJCC/UICC 9th edition stage IB-II（The participants were required to have no extensive skull base invasion and lymph nodes < 4 cm before treatment）. It aimed to adaptively guide the reduction of radiation dose for nasopharyngeal carcinoma based on the response to induction chemotherapy, thereby minimizing radiation-related toxicity while ensuring local control. Cohort 1 was randomly assigned 1:1 to the 59.4 Gy/27 fractions group and the 66.0 Gy/30 fractions group and compared their LRFFS. The participants were required to have EBV-DNA = 0 and CR or PR > 50% after 2 courses of induction therapy. Those who did not meet the criteria were assigned to Cohort 2 to receive standard-dose radiotherapy combined with concurrent cisplatin to avoid excessive reduction of intensity for potentially high-risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: reduced dose groupreduced dose group |
| Control group | Active comparator | Radiation: Standard Dose Groupstandard dose group |
| Corhort 2 | Other | Other: concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduced dose group59.4 Gy/27F | Radiation | Experimental group |
| Standard Dose Group66 Gy/30F | Radiation | Control group |
| concurrent chemoradiotherapy66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2 | Other | Corhort 2 |
Primary outcome
2-year Locoregional Failure-Free Survival，2-y LRFFS
Time frame: 2 year
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.
6 secondary outcomes
2-year Failure-Free Survival，2-y FFS
Time frame: 2 year
2-year Overall Survival，2-y OS
Time frame: 2 year
2-year Distant Failure-Free Survival，2-y DFFS
Time frame: 2 year
Acute Adverse Events，acute AEs
Time frame: up to 90 days after radiotherapy
Late Adverse Events，late AEs
Time frame: After 90 days of radiotherapy to the date of death，assessed up to 2 years or more.
Quality of Life，QoL (EORTC QLQ-H&N35）
Time frame: baseline and up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiayun He principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing reduced dose group, Standard Dose Group and concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiayun He, MD (+86021-64175590-81412, hexiayun1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Locoregional Failure-Free Survival，2-y LRFFS (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.