| CTRI Number |
CTRI/2025/03/082341 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Phase II non inferiority trial. Avoiding elective nodal irradiation in Oral cavity Squamous cell carcinoma of well lateralised buccal mucosa lesion and well lateralised tongue lesion , Post upfront surgery of the primary disease and adequate Elective Nodal dissection, in a pT-T4 and pN0/pN1 Neck |
|
Scientific Title of Study
|
AVOIDING ADJUVANT PROPHYLACTIC NECK IRRADIATION IN LATERALIZED
ORAL CAVITY CANCER (APRON): A PHASE II Non-Inferiority study
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| Trial Acronym |
APRON |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shwetabh Sinha |
| Designation |
Assistant Professor, TMH , Mumbai |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
Room No. 205D, 2nd floor, Paymaster Shodika, ACTREC, Kharghar, Navi Mumbai 410210 OPD No. 206, 2nd floor Homi Bhabha block , Tata Memorial hospital,Dr. Ernest Borges Road
Parel
Mumbai 400012 Mumbai MAHARASHTRA 410210 India |
| Phone |
02224177262 |
| Fax |
|
| Email |
shwetabhsinha23@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shwetabh Sinha |
| Designation |
Assistant Professor, TMH , Mumbai |
| Affiliation |
Assistant professor at Tata Memorial Hospital , Mumbai |
| Address |
Room No. 205D, 2nd floor, Paymaster Shodika, ACTREC, Kharghar, Navi Mumbai 410210 OPD No. 206, 2nd floor Homi Bhabha block , Tata Memorial hospital,Dr. Ernest Borges Road
Parel
Mumbai 400012 Mumbai MAHARASHTRA 410210 India |
| Phone |
02224177262 |
| Fax |
|
| Email |
shwetabhsinha23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pranav Narayan Bishnu |
| Designation |
Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
OPD No. 206, 2nd floor Homi Bhabha block , Tata Memorial hospital,Dr. Ernest Borges Road
Parel
Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
| Phone |
8074989387 |
| Fax |
|
| Email |
pranavnarayanbishnu@gmail.com |
|
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Source of Monetary or Material Support
|
| TATA MEMORIAL HOSPITAL, PAREL, MUMBAI, INDIA, 400012, |
|
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Primary Sponsor
|
| Name |
TATA MEMORIAL CENTRE DEPARTMENT OF ATOMIC ENERGY CLINICAL TRIAL CENTRE |
| Address |
TATA MEMORIAL HOSPITAL, Dr. E. Borges Marg PAREL, MUMBAI, INDIA 400012 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr sambit Nanda |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre And Homi Bhabha Cancer Hospital |
Varanasi, Varanasi UTTAR PRADESH |
7753864021
sambit.sambitswarup@gmail.com |
| Dr Shwetabh Sinha |
Tata Memorial Hospital |
11th floor, Homi,baba block , Tata Memorial Hospital Mumbai MAHARASHTRA |
02224177262
shwetabhsinha23@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Mahamana Pandit Madan Mohan Malaviya Cancer Centre & Homii Bhabha Cancer Hospital, Varanasi |
Approved |
| TMC IEC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Avoiding prophylactic irradiation to the lymph nodes of the neck in early-stage oral cavity cancers, post adequate neck dissection. |
evaluate the feasibility of the omission of elective neck nodal RT to the pN0/pN1 neck in patients with adequately resected non-high-risk oral cancers
For pN0 tumors of the gingivo-buccal complex, the target volume will include the tumor bed (treated to a dose of 60Gy/30 fractions/ 6 weeks or equivalent) and ipsilateral Ib, IIa, and IIb regions (treated to a dose of 54Gy/30 fractions/ 6 weeks or equivalent)
For pN0 tumors of the tongue, the target volume will include the tumor bed (treated to a dose of 60Gy/30 fractions/ 6 weeks or equivalent) and ipsilateral Ib, IIa, IIb and III regions (treated to a dose of 54Gy/30 fractions/ 6 weeks or equivalent).
For pN1 tumors of the gingivo-buccal complex, the tumor bed and the entire involved nodal level will be treated to a 60Gy/30 fractions/ 6 weeks or equivalent. The remainder of levels Ib and II and the nodal level immediately below the involved nodal level (e.g., level III if level II is involved) will receive a dose of 54Gy/30 fractions/ 6 weeks or equivalent.
For pN1 tongue tumors, the tumor bed and the entire involved nodal level will be treated to 60Gy/30 fractions/ 6 weeks or equivalent. The remainder of levels Ib,II, and III and the nodal level immediately below the involved nodal level (e.g., level IV if level III is involved) will receive a dose of 54Gy/30 fractions/ 6 weeks or equivalent.
|
| Comparator Agent |
N/A |
N/A |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Buccal mucosa cancers
Bucco-alveolar region. Biopsy proven SCC and Any stage pT1-pT4a, pN0/N1 and has undergone adequate margin negative surgery as per institutional protocol. Adequate node dissection of 18 nodes and tumor not crossing the midline. Willing to sign ICF
Tongue tumors
Well lateralized tumors of the tongue 1-1.5cms from the midline or Tip of tongue involvement on baseline. Biopsy-proven SCC. Any T Stage pT1-pT4a. pN0/N1(except Ia). Has undergone upfront adequate margin negative surgery (as per institutional protocol). Minimum of 18 nodes dissected. No Contralateral node dissection. Willing to sign Informed Consent form (ICF). Age more than 18 years
|
|
| ExclusionCriteria |
| Details |
2) Exclusion Criteria
a) Synchronous /Metachronous tumours
b) Unlikely to complete full course RT or follow up visits
c) Patients with more than three risk factors such as
i. PDSCC
ii. Worst pattern of invasion 5
iii. Lymphovascular invasion
iv. Perineural invasion
d) Previous history of head and neck cancer treated with surgery other than biopsy /FNAC
e) Previous history of RT
f) No more than 3 comorbidities like diabetes mellitus, hypertension, dyslipidaemia, comorbidities relating to heart such as IHD
g) Pregnant nursing mother
h) People unable to give consent
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Regional Recurrences. 2 years post-treatment: This will be defined as any nodal recurrence (isolated or in combination with local recurrence) occurring in ipsilateral or contralateral levels Ia - X nodal levels (as defined by Gregoire et al.).The regional recurrences will be diagnosed either radiologically or histologically or both |
Subjects fulfilling the criteria of inclusion /exclusion, having provided with consent form will be eligible for participation. Duration of enrolment will be for 36 months. Total duration of study will be of 5 years with follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Swallowing function will be assessed using the MDADI scoring system. Local recurrence rate. Regional recurrence rate. Locoregional recurrence rate. Disease free survival. Overall survival rate. Toxicity assessment. Salvage rates of recurrence (surgery/ RT / Systmic therapy).MD Anderson lymphedema scoring system |
Follow up will be done every 3 months post treatment, with appropriate, investigational techniques & QOL sheets for the first one year & then every 6 months for the second year. Pt will still be called for regular follow ups post 2 years of follow up.
|
|
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Target Sample Size
|
Total Sample Size="106" Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Cancers of the head and neck are one of the most common cancers in India, with approximately 2,50,000 new cases detected annually. Approximately 40% of these cancers are oral cavity cancers. Oral cavity cancers have a strong epidemiology from exposure to tobacco and alcohol. The first step after detecting a doubtful lesion in the oral cavity is a clinical examination followed by a pathological and radiological examination. This is generally followed by surgery to remove the primary tumor and the draining lymph nodes.The pathologist examines post-surgery, the removed lesion, and high-risk features are determined on examination, and a report is made. Based on the final report, Patients are advised to undergo radiation radiotherapy (RT) or chemoradiotherapy (CTRT) to remove the microscopic disease and prevent recurrences. Current standard practices mandate the RT to be given to the primary tumor site and the draining lymph nodes,i.e., almost the entire neck region. Due to the high amount of radiation being given to the structures of the neck,this is associated with increased risk side effects such as difficulty in swallowing, painful swallowing, and food going into the lungs. Many patients (approximately 30-40%) require long durations of assisted swallowing to manage these complications by utilizing external food pipes passed through either the nose or directly put in the bowel. This severely affects the quality of life of patients. Some studies report that to reduce these side effects in patients with an adequate number of lymph nodal tissue removed with surgery,RT can be avoided to the neck nodal region in those patients where the surgically removed neck nodes do not show involvement by the cancer (pN0/pN1). In this study, patients with oral cavity cancers of the buccal mucosa and well-lateralized tongue who have been treated surgically for the primary site and have undergone adequate neck dissection with a minimum of 18 lymph nodes removed and are pN0/pN1 are included. After discussion in the multidisciplinary joint clinic, RT is indicated after surgery, we will treat only the region of the primary tumor and nearby neck nodal regions at maximum risk of relapse. We will omit RT to the neck nodal regions with lesser chances of relapse. This study will help us determine if RT to the uninvolved low risk nodal region is required after adequate surgery. This will also help us to know if sparing of these low-risk neck nodal regions is associated with a better side effect profile for these patients. |