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CTRI Number  CTRI/2022/02/040311 [Registered on: 15/02/2022] Trial Registered Prospectively
Last Modified On: 03/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Eliminate Trial This trial will consider omission of radiotherapy to the neck in patients with N0/N1 nodal status for oral cavity carcinomas with high risk features  
Scientific Title of Study   The Eliminate Trial: A Phase II/III randomised trial evaluating omission of radiotherapy to regional lymphatic’s in pN0/N1 neck for Oral Cavity carcinomas 
Trial Acronym  The Eliminate Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aman Sharma 
Designation  Assistant Professor 
Affiliation  Assistant Professor, NCI-AIIMS 
Address  Department of Radiation Oncology, NCI, AIIMS-Jhajjar, Haryana
Department of Radiation Oncology, NCI, AIIMS-Jhajjar, Haryana
Jhajjar
HARYANA
124105
India 
Phone  07018529339  
Fax    
Email  amans757@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aman Sharma 
Designation  Assistant Professor 
Affiliation  NCI AIIMS Jhajjar 
Address  Department of Radiation Oncology, NCI, AIIMS-Jhajjar, Haryana
Department of Radiation Oncology, NCI, AIIMS-Jhajjar, Haryana
Jhajjar
HARYANA
124105
India 
Phone  07018529339  
Fax    
Email  amans757@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aman Sharma 
Designation  Assistant Professor 
Affiliation  NCI AIIMS Jhajjar 
Address  Department of Radiation Oncology, NCI, AIIMS-Jhajjar, Haryana
Department of Radiation Oncology, NCI, AIIMS-Jhajjar, Haryana
Jhajjar
HARYANA
124105
India 
Phone  07018529339  
Fax    
Email  amans757@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, NEW DELHI 
 
Primary Sponsor  
Name  NCI AIIMSJhajjar 
Address  NCI, AIIMS-JHAJJAR, HARYANA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
AMAN SHARMA  National Cancer Institute (NCI)  Department of Radiation Oncology,Room no 17, Academic block, VILLAGE BADSA, JHAJJHAR, HARYANA 124105
Jhajjar
HARYANA 		 7018529339

amans757@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Post operative radiotherapy to primary site and regional lymphatics  Post operative radiotherapy to primary site and regional lymphatics (neck) for 6 weeks 
Intervention  Post operative radiotherapy to primary site only  Post operative radiotherapy to primary site only for 6 weeks. No Radiotherapy to the neck. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Aged 18 or above and less than 70 years
2) Stage pT1-4 histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
3) Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
4) At least one dissected hemi-neck with adequate pathologically lymph node dissection (at least 18 nodes recovered in one dissected hemi-neck)
5) Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC ofthe oral cavity.
6) Karnofskyperformace score greater or equal 70
7) Ability to complete the MD Anderson Dysphagia Inventory (MDADI)and EORTC quality of life questionnaires English or Hindi Version.
8) Timely delivery of PORT preferable within 6weeks of surgery (upto 1-2 weeks of delay beyond 6 weeks is permissible to accommodate for delayed wound healing or other logistics)
9) Written informed consent for treatment.
10) Available to attend long term follow- up
 
 
ExclusionCriteria 
Details  1) Non squamous histology
2) Presences of distant metastases
3) pT1-2 disease and no high risk features
4) Pathologically N2/N3 disease.
5) Delivery of neo-adjuvant chemotherapy before surgery
6) Patients that require re-irradiation for recurrent disease
7) Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done
8) Initiation of PORT after 8 weeks of radical surgery.
9) Previous radiotherapy to the head and neck region
10) Any invasive malignancy within previous 2 years (other than nonmelanomatous skin carcinoma or cervical carcinoma in situ).
11) Age < 18 years or > 70 years
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Difference in regional control in irradiated versus un-irradiated neck at 2 years.   1. Difference in regional control in irradiated versus un-irradiated neck at 2 years.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Treatment outcomes loco control, regional control, disease free survival and overall survival as assessed at follow-up visits 3, 6, 12, 18 and 24 months post treatment and then annually until 5 years post treatment
2. Swallowing function, assessed by using the MDADI at baseline, 3, 6, 12, and 24 months.
3. Acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, 18 and 24 months assessed by RTOG & LENT SOMA scale

 		 2 YEARS
 
 
Target Sample Size   Total Sample Size="396"
Sample Size from India="396" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/02/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amans757@gmail.com].

  6. For how long will this data be available start date provided 11-01-2025 and end date provided 11-05-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Locoregional recurrence is the predominant cause of mortality in oral cavity carcinomas. Oral cavity carcinomas are often treated with combination of radical surgery and adjuvant radiation (RT) based on pathological findings. Risk stratification is often used for selecting patients with unfavorable risk factors for which adjuvant postoperative adjuvant therapy ± concomitant chemotherapyis administered.Post-operative radiotherapy (PORT) in recommended in patients with high risk features of recurrence these include extracapsular extension, positive/ close margins, pathologically T3-4 disease, more than one lymph node involvement, lymph vascular space invasion (LVSI), perineural invasion (PNI). Addition of chemotherapy to radiotherapy has been shown to improve treatment outcomes in patients with extra-nodal extension and margin positive disease.

PORT is delivered to the tumor bed and regional lymphatics. Depending upon the histopathological features and location of primary tumor, unilateral or bilateral neck portals are used to addressthe microscopic disease after surgery. Delivery of PORT is patients with high risk features is associated with improvement in locoregional control as well as overall survival. However, the benefit of PORT is associated withdevelopment of significant acute and late radiation induced morbidities. These include including dysphagia, aspiration, mucositis, altered taste sensation, xerostomia, dermatitis, fibrosis, osteoradionecrosis, voice changes, stricture, ototoxicity and hypothyroidism.

Larger RT treatment volumes are often associated with increased toxicity. At present there areno guidelines to that define use of local versus loco-regional PORT portals for oral cavity carcinomas. Retrospective series have demonstrated that omission of PORT to regional lymphatics in N0-N1 disease with adverse histopathological features is safe and feasible. Omission of PORT in these series has shown low rates of isolated nodal recurrence that rangefrom 8%- 15%. Given the lack of robust evidence for omission of PORT to regional lymphatics in patients with adverse histopathological risk factors in pN0-N1oral cavity, a prospective randomized trial is warranted. The present study is a phase II/III prospective randomized trial designed to determine whether the omission of PORT to regional lymphatics in adequately dissected neck in pN0-N1oral cavity is associated with similar/ improved treatment outcomes.  
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