RadiotherapyNCT05455632
Postoperative Radiotherapy for Oral Squamous Cell Carcinoma After Neoadjuvant Therapy and Surgery
An observational study of Radiotherapy and Neoadjuvant Therapy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The treatment guideline for locally advanced resectable oral squamous cell carcinoma (LAROSCC) is surgery + postoperative radiotherapy/chemoradiotherapy. Though the treatment is intensive with serious harm to quality of life, the survival of patients is poor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiotherapy, Neoadjuvant Therapy, Oral Squamous Cell Carcinoma
- Type of treatment
- Pill or oral medicine
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Apr 2023
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy and surgery with and without postoperative radiotherapy in the Department of Oral and Maxillofacial-Head and Neck Oncology in Ninth People's Hospital, Shanghai JiaoTong University School of Medicine from January 2008 to December 2021.
Who may be able to join
- Patients receiving neoadjuvant therapy and surgery for oral squamous cell carcinoma from January 2008 to December 2021
- Oral squamous cell carcinoma histology (including tongue, gingiva, cheek, floor of mouth, hard palate and posterior molar area)
- Clinical stage III/IVA (T1-2/N1-2/M0 or T3-4/cN0-2/M0, AJCC 2018) for the primary lesion
- Surgical resection samples that can be evaluated for pathological remission rate
Who cannot join
- Severe/active systemic disease
- Previously radiotherapy or neck lymph node dissection for the head and neck region
- Evidence of tumor recurrence or metastasis in physical examination or imaging (ultrasound, CT, MRI) before initiation adjuvant radiotherapy
- Evidence of severe/unrelieved side effects of neoadjuvant therapy or severe postoperative complications before initiation adjuvant radiotherapy
Trial locations and contacts
1 site in 1 country.
China1 site
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 20011
About this study
Official title: Can Postoperative Radiotherapy be Omitted for Oral Squamous Cell Carcinoma Patients Underwent Neoadjuvant Therapy and Surgery? - A Retrospective Cohort Study
The treatment guideline for locally advanced resectable oral squamous cell carcinoma (LAROSCC) is surgery + postoperative radiotherapy/chemoradiotherapy. Though the treatment is intensive with serious harm to quality of life, the survival of patients is poor. Neoadjuvant therapy has been evaluated in a number of clinical trials for LAROSCC, but failed to directly improve the overall survival. On the other hand, de-escalation of treatment followed by neoadjuvant is also been explored with some promising results. This study is to retrospectively include patients with LAROSCC who received neoadjuvant therapy and surgery. Survival between patients in two cohorts (cohort 1: received postoperative radiotherapy, cohort 2: received no postoperative radiotherapy) are to be compared.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1:PORT | Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy, surgery, and postoperative radiotherapy. | |
| Group2:non-PORT | Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy and surgery, without postoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival
Measured: 24 months
Secondary outcomes (3)
LRFS
Local recurrence-free rate
Measured: 24 months
QOL
Quality of life (QOL), according to the QLQ-C30 scoring manual, the final QOL scores of each field are transformed into standardized scores within 0-100 through linear transformation
Measured: 24 months
OS-MPR
Overall survival for patients obtained major pathological response (MPR) from neoadjuvant therapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Dec 2022
- Study completion30 Apr 2023
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 RadiotherapyStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine
- Investigators
- Lai-ping Zhong, Principal investigator, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455632
- Sponsor's protocol ID
- PORT-NAT
- Status last verified
- Nov 2023
- First submitted
- 9 Jul 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ju W, Zhang Y, Liu Y, Sun J, Li J, Dong M, Sun Q, Shi W, Zhao T, Zhou Z, Huang Y, Zhou X, Zhu D, Dou S, Zhang Z, He Y, Zhang C, Xia R, Zhu G, Zhong L. Can adjuvant radiotherapy be omitted for oral cavity cancer patients who received neoadjuvant therapy and surgery? A retrospective cohort study. Int J Surg. 2023 Apr 1;109(4):879-886. doi: 10.1097/JS9.0000000000000353.
PubMed 36999830
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Postoperative Radiotherapy be Omitted for Oral Squamous Cell Carcinoma Patients Underwent Neoadjuvant Therapy and Surgery? - A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05455632
- Acronym / sponsor ID
- PORT-NAT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 13 Jul 2022 (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.
The treatment guideline for locally advanced resectable oral squamous cell carcinoma (LAROSCC) is surgery + postoperative radiotherapy/chemoradiotherapy. Though the treatment is intensive with serious harm to quality of life, the survival of patients is poor. Neoadjuvant therapy has been evaluated in a number of clinical trials for LAROSCC, but failed to directly improve the overall survival. On the other hand, de-escalation of treatment followed by neoadjuvant is also been explored with some promising results. This study is to retrospectively include patients with LAROSCC who received neoadjuvant therapy and surgery. Survival between patients in two cohorts (cohort 1: received postoperative radiotherapy, cohort 2: received no postoperative radiotherapy) are to be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1:PORT | – | –Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy, surgery, and postoperative radiotherapy. |
| Group2:non-PORT | – | –Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy and surgery, without postoperative radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy and surgery with and without postoperative radiotherapy in the Department of Oral and Maxillofacial-Head and Neck Oncology in Ninth People's Hospital, Shanghai JiaoTong University School of Medicine from January 2008 to December 2021.
Key inclusion criteria (4 listed)
- Patients receiving neoadjuvant therapy and surgery for oral squamous cell carcinoma from January 2008 to December 2021
- Oral squamous cell carcinoma histology (including tongue, gingiva, cheek, floor of mouth, hard palate and posterior molar area)
- Clinical stage III/IVA (T1-2/N1-2/M0 or T3-4/cN0-2/M0, AJCC 2018) for the primary lesion
- Surgical resection samples that can be evaluated for pathological remission rate
Key exclusion criteria (4 listed)
- Severe/active systemic disease
- Previously radiotherapy or neck lymph node dissection for the head and neck region
- Evidence of tumor recurrence or metastasis in physical examination or imaging (ultrasound, CT, MRI) before initiation adjuvant radiotherapy
- Evidence of severe/unrelieved side effects of neoadjuvant therapy or severe postoperative complications before initiation adjuvant radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OS
Time frame: 24 months
Overall survival
3 secondary outcomes
LRFS
Time frame: 24 months
QOL
Time frame: 24 months
OS-MPR
Time frame: 24 months
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 22 Nov 2023.
- Derived from this study: PubMed 36999830Ju W, Zhang Y, Liu Y, Sun J, Li J, Dong M, Sun Q, Shi W, Zhao T, Zhou Z, Huang Y, Zhou X, Zhu D, Dou S, Zhang Z, He Y, Zhang C, Xia R, Zhu G, Zhong L. Can adjuvant radiotherapy be omitted for oral cavity cancer patients who received neoadjuvant therapy and surgery? A retrospective cohort study. Int J Surg. 2023 Apr 1;109(4):879-886. doi: 10.1097/JS9.0000000000000353.
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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. This study is not recruiting at the moment.
Lai-ping Zhong principal investigator
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy and Neoadjuvant Therapy, run by Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 4 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 22 Nov 2023. 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.
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?
OS (time frame: 24 months). 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 NCT05455632, 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 22 Nov 2023.