Head and Neck CancerPhase 2/3EliminateNCT07528495
A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
A Phase 2/3 study testing IMRT - adjuvant concurrent CRT/ RT, ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics and Cisplatin in people with Head and Neck Cancer, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- IMRT - adjuvant concurrent CRT/ RT, ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteIndia
- Study dates
- 3 Apr 2024to 3 Apr 2028
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or above and less than 70 years
- Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
- Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
- At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)
- Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity
- Brandwein-Gensler (BG) histological risk assessment in all patients
Show all 11Show fewer
- Karnofsky performance score greater or equal 70
- Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
- 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)
- Written informed consent for treatment.
- Available to attend long term follow- up
Who cannot join
- Non squamous histology
- Presences of distant metastases
- pT1-2 disease and no high risk features
- Pathologically N2/N3 disease.
- Patients that require re-irradiation for recurrent disease
- Inadequate neck dissection (less than 12 nodes examined)
Show all 12Show fewer
- Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done
- Initiation of PORT after 8 weeks of radical surgery.
- Previous radiotherapy to the head and neck region
- Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
- Age < 18 years or > 70 years
- Brandwein-Gensler (BG) histological risk not done
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Nci, Aiims
Jhajjar, Haryana, 124105
Aman Sharma, MD, +917018529339, amans757@gmail.com
About this study
Official title: 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
The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.
Read the detailed description
Patients of oral cavity squamous cell carcinoma (OCSCC) undergoing surgery are at risk of local as well as regional failure. Postoperative radiotherapy (PORT) is often added to radical surgery with intent to reduce loco regional recurrence and improve overall survival in patients with high-risk features. High risk feature include patients with extra capsular extension, positive/ close margins, more than one lymph node involved, pT3 or pT4 primary disease, lymphovascular invasion (LVI), perineural invasion (PNI). PORT alone or in combination with concurrent chemotherapy is associated with reductions in loco regional recurrence as well as improvement in overall survival (OS). Benefits associated with PORT often come at the expense of development of significant acute and late morbidities that include dysphagia, mucositis, xerostomia, dermatitis, ototoxicity, fibrosis, dental caries, osteoradionecrosis, change in voice changes, and hypothyroidism.
Radiotherapy (RT) portals for head and neck squamous cell carcinomas (HNSCC) have traditionally included primary disease plus treatment of bilateral neck. Larger RT treatment volumes generally correlate with increased incidence of radiation induced morbidity .There is potential to reduce radiation morbidity if RT portals can be reduced without compromising treatment outcomes. One such situation is pN0-pN1neck status. However, at present there is no definite consensus as regards to omission of PORT to regional lymphatic's in pN0 -pN1neck and the benefit of omission of PORT largely remains unknown.
In a non randomized prospective phase II trial, that eliminated PORT to pN0 necks for patients with locally advanced HNSCC, showed that omitting PORT resulted in excellent control rates in the unirradiated neck. This study included 19% patients with OCSCC. Several retrospective series for OCSCC have reported that RT to tumor bed alone in N0-1 neck is associated with similar treatment outcomes as compared to RT to loco-regional sites.The ongoing PRESERVE study is addressing this question and will generate high level evidence in terms of oncologic outcomes, quality of life and toxicity.The PRESERVE study is a multicentre phase II study randomizing 90 patients with T1-4 N0-2 OCSCC with at least one pN0hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). The Eliminate trial is similar to the PRESERVE study but will exclude patients with PN2-pN3 disease. Unlike the PRESERVE study, the ongoing trial will also consider omission PORT in patients with pN1 disease.
A risk of nodal recurrence of 15%-20% has traditionally an indication warrant radiation to a nodal basin. Involvement of two or more nodes is a definite indication for PORT. However, in patients in whom the metastases are limited to a single, ipsilateral positive lymph node not larger than 3 cm (ie, N1), and the routine use of PORT is controversial. In such situations PORT delivery is at discretion of the treating physician. This discrepancy (pN1 status) was also seen in EORTC trial 22931 and RTOG trial 9501criteria for definition of high risk disease. In the EORTC trial 43% of patients enrolled in the trial hadpN0-1 status whereas only 6% of the patients enrolled in the RTOG trial hadpN0-1. The RTOG used the criteria of two or more lymph nodes as indication of PORT whereas in the EORTC trial stage III -IV were one of the criteria for delivery of PORT. There is no prospective study that has considered omission of PORT in pN1OCSCC.
Large retrospective series have demonstrated the benefit of PORT for pN1 disease yet there is declining uses of PORT for pN1 OSCC .The ASCO guidelines also do not recommend PORT in pN1 after adequate neck dissection. A recently published study of the National Cancer Database that comprised 1909 OSCC patients with pN1 disease showed a statistically significant survival benefit in favour of PORT (adjusted HR 0.82). The study reported similar benefit in patients with inadequate and adequate neck dissections. In light of this background, the Eliminate trial is designed to test omission of regional RT in pN0-1 neck.
The aim of this study is evaluate feasibility of omission of RT to regional lymphatics in pN0/pN1 patients undergoing radical surgery with adequate lymph node dissection for oral cavity HNSCC.
- Conditions
- Head and Neck Cancer
- Being tested
- IMRT - adjuvant concurrent CRT/ RT, ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics, Cisplatin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT - adjuvant concurrent CRT/ RTRadiation
IMRT - adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr to primary and regional lymphatics
ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphaticsRadiation
IMRT- adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr / Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only
- elimination of regional lymphatics
CisplatinDrug
Cisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Post operative radiotherapy to primary tumor bed and regional lymphatics Receives: Radiation: IMRT - adjuvant concurrent CRT/ RT; Drug: Cisplatin |
| Arm B | Experimental | Post operative radiotherapy to primary tumor bed but omission of PORT to regional lymphatics Receives: Radiation: ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional control
Regional control will be assessed as occurrence of any new lesion in the regional /nearby area over time with the help of radiological imaging (CT/MRI/PET-CT) and clinical examination.
will be assessed at 3 months, 6 months, 12 months, 18 months, 24 months
Measured: 2 years
Secondary outcomes (8)
Local control
Local control will assess the recurrence within the primary tumor site at its original location. Radiographic assessment (CT/MRI/PET-CT) at 3, 6, 12, 18 and 24 months
Measured: 2 years
Disease free survival
assessed as the length of time that a patient survives without any signs and symptoms of the disease and assessment will be done at every 3, 6, 12, 18, 24 months
Measured: 2 years
Overall survival
longitudinal assessment every 3, 6, 12, 18, 24 months
Measured: 2 years
Acute toxicity
Acute toxicity is the side effects that appear within 90 days after the radiation therapy and will be assessed using RTOG acute toxicity scale with grading from 0 to IV where 0 represents no findings and IV being the worst Findings. Higher values wiill be showing worsening of the condition.
it will be scored weekly during radiation.
Measured: 2 years
late toxicity
late toxicity is the side effects that appear after 90 days following the radiation therapy and will be assessed using the Late effects in normal tissues- subjective, objective, management, analytic (LENT SOMA) scale with maximum value of 4 showing very severe / disabling and minimum value of 0 showing no toxicity. Higher values wiill be showing worsening of the condition.
longitudinal assessment will be done every 3, 6, 12, 18, 24 months
Measured: 2 years
Swallowing function
MD Anderson Dysphagia Inventory pre RT, post RT, 3, 6, 12, 18, 24 months
Measured: 2 years
Quality of life EORTC QLQ C30
EORTC QLQC30 module [longitudinal assessment at 3, 6, 12, 18 and 24 months] The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 2 years
Quality of life H&N 35
EORTC H\&N 35 module [longitudinal assessment at 3, 6, 12, 18 and 24 months]
The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales (maximum score 100 and minimum score 0), high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H\&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start3 Apr 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Rishikesh, All India Institute of Medical Sciences, Raipur, Jawaharlal Institute of Postgraduate Medical Education & Research
- Responsible party
- Principal investigator, Aman Sharma, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528495
- Sponsor's protocol ID
- The Eliminate Trial
- Acronym
- Eliminate
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07528495
- Acronym / sponsor ID
- Eliminate / The Eliminate Trial
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Rishikesh, All India Institute of Medical Sciences, Raipur, Jawaharlal Institute of Postgraduate Medical Education & Research
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 14 Apr 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.
The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.
Detailed description
Patients of oral cavity squamous cell carcinoma (OCSCC) undergoing surgery are at risk of local as well as regional failure. Postoperative radiotherapy (PORT) is often added to radical surgery with intent to reduce loco regional recurrence and improve overall survival in patients with high-risk features. High risk feature include patients with extra capsular extension, positive/ close margins, more than one lymph node involved, pT3 or pT4 primary disease, lymphovascular invasion (LVI), perineural invasion (PNI). PORT alone or in combination with concurrent chemotherapy is associated with reductions in loco regional recurrence as well as improvement in overall survival (OS). Benefits associated with PORT often come at the expense of development of significant acute and late morbidities that include dysphagia, mucositis, xerostomia, dermatitis, ototoxicity, fibrosis, dental caries, osteoradionecrosis, change in voice changes, and hypothyroidism.
Radiotherapy (RT) portals for head and neck squamous cell carcinomas (HNSCC) have traditionally included primary disease plus treatment of bilateral neck. Larger RT treatment volumes generally correlate with increased incidence of radiation induced morbidity .There is potential to reduce radiation morbidity if RT portals can be reduced without compromising treatment outcomes. One such situation is pN0-pN1neck status. However, at present there is no definite consensus as regards to omission of PORT to regional lymphatic's in pN0 -pN1neck and the benefit of omission of PORT largely remains unknown.
In a non randomized prospective phase II trial, that eliminated PORT to pN0 necks for patients with locally advanced HNSCC, showed that omitting PORT resulted in excellent control rates in the unirradiated neck. This study included 19% patients with OCSCC. Several retrospective series for OCSCC have reported that RT to tumor bed alone in N0-1 neck is associated with similar treatment outcomes as compared to RT to loco-regional sites.The ongoing PRESERVE study is addressing this question and will generate high level evidence in terms of oncologic outcomes, quality of life and toxicity.The PRESERVE study is a multicentre phase II study randomizing 90 patients with T1-4 N0-2 OCSCC with at least one pN0hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). The Eliminate trial is similar to the PRESERVE study but will exclude patients with PN2-pN3 disease. Unlike the PRESERVE study, the ongoing trial will also consider omission PORT in patients with pN1 disease.
A risk of nodal recurrence of 15%-20% has traditionally an indication warrant radiation to a nodal basin. Involvement of two or more nodes is a definite indication for PORT. However, in patients in whom the metastases are limited to a single, ipsilateral positive lymph node not larger than 3 cm (ie, N1), and the routine use of PORT is controversial. In such situations PORT delivery is at discretion of the treating physician. This discrepancy (pN1 status) was also seen in EORTC trial 22931 and RTOG trial 9501criteria for definition of high risk disease. In the EORTC trial 43% of patients enrolled in the trial hadpN0-1 status whereas only 6% of the patients enrolled in the RTOG trial hadpN0-1. The RTOG used the criteria of two or more lymph nodes as indication of PORT whereas in the EORTC trial stage III -IV were one of the criteria for delivery of PORT. There is no prospective study that has considered omission of PORT in pN1OCSCC.
Large retrospective series have demonstrated the benefit of PORT for pN1 disease yet there is declining uses of PORT for pN1 OSCC .The ASCO guidelines also do not recommend PORT in pN1 after adequate neck dissection. A recently published study of the National Cancer Database that comprised 1909 OSCC patients with pN1 disease showed a statistically significant survival benefit in favour of PORT (adjusted HR 0.82). The study reported similar benefit in patients with inadequate and adequate neck dissections. In light of this background, the Eliminate trial is designed to test omission of regional RT in pN0-1 neck.
The aim of this study is evaluate feasibility of omission of RT to regional lymphatics in pN0/pN1 patients undergoing radical surgery with adequate lymph node dissection for oral cavity HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Radiation: IMRT - adjuvant concurrent CRT/ RT, Drug: CisplatinPost operative radiotherapy to primary tumor bed and regional lymphatics |
| Arm B | Experimental | Radiation: ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics, Drug: CisplatinPost operative radiotherapy to primary tumor bed but omission of PORT to regional lymphatics |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 or above and less than 70 years
- Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
- Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
- At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)
- Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity
Key exclusion criteria (12 listed)
- Non squamous histology
- Presences of distant metastases
- pT1-2 disease and no high risk features
- Pathologically N2/N3 disease.
- Patients that require re-irradiation for recurrent 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 |
|---|---|---|
| IMRT - adjuvant concurrent CRT/ RTIMRT - adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr to primary and regional lymphatics | Radiation | Arm A |
| ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphaticsIMRT- adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr / Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only - elimination of regional lymphatics | Radiation | Arm B |
| CisplatinCisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease. | Drug | Arm A, Arm B |
Primary outcome
Regional control
Time frame: 2 years
Regional control will be assessed as occurrence of any new lesion in the regional /nearby area over time with the help of radiological imaging (CT/MRI/PET-CT) and clinical examination. will be assessed at 3 months, 6 months, 12 months, 18 months, 24 months
8 secondary outcomes
Local control
Time frame: 2 years
Disease free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Acute toxicity
Time frame: 2 years
late toxicity
Time frame: 2 years
Swallowing function
Time frame: 2 years
Quality of life EORTC QLQ C30
Time frame: 2 years
Quality of life H&N 35
Time frame: 2 years
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 6 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IMRT - adjuvant concurrent CRT/ RT, ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics and Cisplatin in people with Head and Neck Cancer, run by All India Institute of Medical Sciences at 1 site in India.
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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 May 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 India. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aman Sharma, MD (+91117018529339, amans757@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional control (time frame: 2 years). 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 6 May 2026.