Target Volume DelineationPhase 2NCT03839602
Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients
A Phase 2 study testing Reducing CTV in people with Target Volume Delineation and Early-stage Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To analyze the long-term results and toxicities of the reducing clinical target volume (CTV) delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Target Volume Delineation, Early-stage Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy
- What is being tested?
- Reducing CTV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2001to 1 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed NPC (WHO II-III)
- stage I-IIb according to the 6th AJCC/UICC
- no previous treatment for NPC
- between 18 and 70 years old
- KPS ≥ 80 scores
- adequate organ function (white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥ 1.5×109/L; hemoglobin ≥ 100g/L; platelet count ≥ 100×109/L; total bilirubin, aspartate aminotransferase and alanine aminotransferase ≤ 1.5X upper limit normal; and creatinine clearance rate ≥ 30 mL/min)
Who cannot join
- fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT
- disease progression during IMRT
- presence of distant metastasis
- pregnancy or lactation
- previous malignancy or other concomitant malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal
To analyze the long-term results and toxicities of the reducing clinical target volume (CTV) delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT).
Read the detailed description
The investigators designed a prospective phase II study for early-stage NPC patients, and proposed a reasonable delineation method of reducing CTV according to the clinical characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and prophylactic dose to CTV while protecting as much normal tissues as possible, in order to ensure a long-term survival with good quality of life.
- Conditions
- Target Volume Delineation, Early-stage Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy
- Being tested
- Reducing CTV
- Keywords
- Locoregional Failure Pattern, Toxicity
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing CTVRadiation
CTVs were delineated in line with tumor stage, i.e. tumor invasion.
| Study group | Role | What they receive |
|---|---|---|
| reducing CTV | Experimental | The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively. Receives: Radiation: Reducing CTV |
What is being measured
The primary outcome is the main question the study is designed to answer.
LRRFS
locoregional recurrence free survival
Measured: 5 year
Secondary outcomes (6)
Locoregional failure patterns
To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence
Measured: 5 year
DMFS
distant metastasis free survival
Measured: 5 year
DSS
disease specific survival
Measured: 5 year
OS
overall survival
Measured: 5 year
Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)
National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)
Measured: 3 months after IMRT
Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
Radiation Therapy Oncology Group radiation morbidity scoring criteria
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 May 2001
- Primary completion31 Oct 2006
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Target Volume DelineationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Not applicable
- Intervention model
- Single group
- Model description
- The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839602
- Sponsor's protocol ID
- CTV Delineation in I-II NPC
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miao J, Di M, Chen B, Wang L, Cao Y, Xiao W, Wong KH, Huang L, Zhu M, Huang H, Huang S, Han F, Deng X, Xiang Y, Lv X, Xia W, Tan SH, Wee JTS, Guo X, Chua MLK, Zhao C. A Prospective 10-Year Observational Study of Reduction of Radiation Therapy Clinical Target Volume and Dose in Early-Stage Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):672-682. doi: 10.1016/j.ijrobp.2020.03.029. Epub 2020 Apr 6.
PubMed 32272183
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal
- ClinicalTrials.gov ID
- NCT03839602
- Acronym / sponsor ID
- CTV Delineation in I-II NPC
- Conditions
- Target Volume Delineation, Early-stage Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy
- Keywords
- Locoregional Failure Pattern, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2001 (actual)
- Primary completion
- 31 Oct 2006 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 15 Feb 2019 (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 analyze the long-term results and toxicities of the reducing clinical target volume (CTV) delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT).
Detailed description
The investigators designed a prospective phase II study for early-stage NPC patients, and proposed a reasonable delineation method of reducing CTV according to the clinical characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and prophylactic dose to CTV while protecting as much normal tissues as possible, in order to ensure a long-term survival with good quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.
| Arm | Type | Receives |
|---|---|---|
| reducing CTV | Experimental | Radiation: Reducing CTVThe gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed NPC (WHO II-III)
- stage I-IIb according to the 6th AJCC/UICC
- no previous treatment for NPC
- between 18 and 70 years old
- KPS ≥ 80 scores
Key exclusion criteria (5 listed)
- fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT
- disease progression during IMRT
- presence of distant metastasis
- pregnancy or lactation
- previous malignancy or other concomitant malignant disease
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 |
|---|---|---|
| Reducing CTVCTVs were delineated in line with tumor stage, i.e. tumor invasion. | Radiation | reducing CTV |
Primary outcome
LRRFS
Time frame: 5 year
locoregional recurrence free survival
6 secondary outcomes
Locoregional failure patterns
Time frame: 5 year
DMFS
Time frame: 5 year
DSS
Time frame: 5 year
OS
Time frame: 5 year
Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)
Time frame: 3 months after IMRT
Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32272183Miao J, Di M, Chen B, Wang L, Cao Y, Xiao W, Wong KH, Huang L, Zhu M, Huang H, Huang S, Han F, Deng X, Xiang Y, Lv X, Xia W, Tan SH, Wee JTS, Guo X, Chua MLK, Zhao C. A Prospective 10-Year Observational Study of Reduction of Radiation Therapy Clinical Target Volume and Dose in Early-Stage Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):672-682. doi: 10.1016/j.ijrobp.2020.03.029. Epub 2020 Apr 6.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Reducing CTV in people with Target Volume Delineation and Early-stage Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 15 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LRRFS (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839602, which also lists 1 linked publication.
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 15 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.