Cancer of MouthARESTNCT03853655
Adjuvant Radiotherapy in Early Stage Oral Cancers
A study testing Post-operative adjuvant radiotherapy in people with Cancer of Mouth and Cancer of the Tongue, run by Tata Memorial Hospital at 8 sites in India.
Trial summary
This study will assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having tumor thickness more than or equal to 5mm. The study population will consist of patients who have been treated by surgery for early stage oral tongue cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Mouth, Cancer of the Tongue, Cancer of the Head and Neck
- What is being tested?
- Post-operative adjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 8 sitesIndia
- Study dates
- 2 Aug 2018to 15 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-operative early stage squamous cell carcinoma of the oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth). (pT1, pT2, N0 as defined in the AJCC Classification 8th edition.
- Adequate surgery (Defined as wide local excision of the primary tumor with tumor-free margin ≥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.)
- Written informed consent.
- Age ≥18 years
- Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2
- The depth of invasion (DOI) ≥ 5 mm.
- Compliance to therapy and follow-up
- The interval from surgery to adjuvant radiotherapy ≤ 6 weeks
Who cannot join
- pT3/pT4 (as specified in the AJCC 8th edition).
- Depth of invasion < 5mm.
- Any neck nodal metastasis with or without extra nodal extension
- Tumor-free margin < 5 mm
- Non-squamous histology
- Pregnant woman
- Prior h/o any other malignancy in the last five years
- Prior therapeutic irradiation of the head and neck.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
HCG Hospital
Ahmedabad, Gujarat, 380006
Sree Sankara Cancer Hospital
Bangalore, Karnataka, 560004
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, 560100
Kailash Cancer Hospital and Research Centre
Goraj, Gujarat, 391760
Dr. B Barooah Cancer Institute
Guwahati, Assam, 781016
Malabar Cancer Centre
Kannur, Kerala, 670103
Amrita Institute of Medical Sciences
Kochi, Kerala, 682041
Tata Memorial Centre
Mumbai, Maharashtra, 400012
About this study
Official title: Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST)
This study will assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having tumor thickness more than or equal to 5mm. The study population will consist of patients who have been treated by surgery for early stage oral tongue cancers. Patients with a close or positive margin (</= 5mm) and or with metastatic neck node(s) will be excluded. Selected patients will be randomized into two groups. The group I will be observed after surgery and group II will receive adjuvant radiotherapy as per protocol.
Read the detailed description
The aim of this study is to assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having a tumor depth of invasion more than or equal to 5mm.
Primary objective:
To determine the impact of postoperative adjuvant radiotherapy on locoregional recurrence-free survival in patients with early-stage oral tongue cancer with tumor thickness ≥ 5 mm.
Secondary objectives:
- To compare disease-free survival and overall survival between the two groups.
- To assess and compare the quality of life changes between the two groups.
- To assess the acute and long-term radiation toxicity.
We will be conducting a Phase III Open-Label Prospective Randomized Controlled Trial using stratified randomization. Patients will be randomized into two groups:
Group I: Control arm (Observation only) Group II: Study arm (Postoperative adjuvant radiotherapy)
Patients will be stratified on the following factors
- Presence of Perineural Invasion (PNI)/Lympho-Vascular Emboli (LVE)
- Histological grade (well-differentiated/moderately differentiated vs poorly differentiated)
- Tongue/Floor of Mouth vs Buccal Mucosa.
Study procedures:
The study population will consist of patients who have been treated by surgery for early-stage oral cancers. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. The depth of invasion will be assessed microscopically by measuring the maximum vertical bulk of the tumor from the normal mucosal surface to the deepest point of invasion. After reviewing the histopathological report, patients will be randomized to one of the 2 arms. Patients belonging to study arm (Group II) will receive adjuvant radiotherapy 60 Gray, 30 fractions for 30 days over 6 weeks as routinely prescribed at Tata Memorial Center (TMC) and will receive the treatment within or by 6 weeks after surgery.
Both the groups (Group I and Group II) will be under regular follow-up with 3 monthly intervals for the first 2 years and 6 monthly for the next 3 years and once a year thereafter. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of randomization and the date of biopsy-proven recurrence. We will also record the overall survival in both groups. The quality of life will be assessed at each follow-up regular intervals using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ H\&N-35 ) and EORTC QLQ-C 30. The radiation toxicity will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
- Conditions
- Cancer of Mouth, Cancer of the Tongue, Cancer of the Head and Neck, Buccal Mucosa Cancer, Floor of Mouth Carcinoma
- Being tested
- Post-operative adjuvant radiotherapy
- Keywords
- Cancer of the Mouth, Tongue cancer, Buccal Mucosa cancer, Head and Neck, Oral Cancer, Adjuvant Radiotherapy, Depth of Invasion
- Medical subject headings
- Mouth Neoplasms, Tongue Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative adjuvant radiotherapyRadiation
Conventional treatment planning, as well as intensity-modulated radiation therapy (IMRT) planning, would be allowed on the study with patients being stratified on the RT technique.
Treatment would be delivered on telecobalt unit (gamma-rays/linear accelerator (6MV photons). All fields would be treated daily.
Phase I: 46 Gray(Gy) in 23 fractions over 4.5 weeks Phase II: 14Gray in 7 fractions over 1.5 weeks
For IMRT, inverse planning would be done on a commercial TPS configured to deliver IMRT using 6MV photons. Patients shall be treated using the simultaneous integrated boost (SIB) technique with 5 fractions being delivered every week.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patients in this arm will be observed and kept under active follow-up after surgery for the primary. |
| Study arm | Experimental | Intervention in the study arm will be in the form of post-operative adjuvant radiotherapy starting within 6-weeks after primary surgery. Receives: Radiation: Post-operative adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
loco-regional recurrence free survival
Measures the number of local or regional recurrences in both arm over a defined time frame.
Measured: Date of randomization to loco regional recurrence (date of proven biopsy date) or at the end of 36 months after recruitment of the last participant.
Secondary outcomes (2)
Disease free survival
time from the beginning of an intervention until patient experiences a recurrence, a new primary cancer or death.
Measured: Calculated as difference of date of randomization to date of first documented recurrence or relapse, second primary or death or at the end of 36 months after recruitment of the last participant.
Overall survival
Date of Randomization to death from any cause
Measured: Date of randomization to death from any cause or at the end of 36 months after recruitment of the last participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start2 Aug 2018
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cancer of MouthStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- NATIONAL CANCER GRID
- Responsible party
- Principal investigator, Dr. Sudhir Nair, Tata Memorial Hospital
- Investigators
- Sudhir V Nair, MS, MCh, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853655
- Sponsor's protocol ID
- 1713
- Acronym
- AREST
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2017
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thiagarajan S, Nair S, Nair D, Chaturvedi P, Kane SV, Agarwal JP, D'Cruz AK. Predictors of prognosis for squamous cell carcinoma of oral tongue. J Surg Oncol. 2014 Jun;109(7):639-44. doi: 10.1002/jso.23583. Epub 2014 Mar 12.
PubMed 24619660Dequanter D, Saint-Aubin N, Paesmans M, Badr-El-Din A, Lothaire P, Andry G. [Prognostic factors in epidermoid carcinoma of the mobile tongue classified as T1-T2]. Ann Otolaryngol Chir Cervicofac. 2001 Oct;118(5):315-22. French.
PubMed 11845040Kokemueller H, Rana M, Rublack J, Eckardt A, Tavassol F, Schumann P, Lindhorst D, Ruecker M, Gellrich NC. The Hannover experience: surgical treatment of tongue cancer--a clinical retrospective evaluation over a 30 years period. Head Neck Oncol. 2011 May 21;3:27. doi: 10.1186/1758-3284-3-27.
PubMed 21600000Ganly I, Patel S, Shah J. Early stage squamous cell cancer of the oral tongue--clinicopathologic features affecting outcome. Cancer. 2012 Jan 1;118(1):101-11. doi: 10.1002/cncr.26229. Epub 2011 Jun 29.
PubMed 21717431Gonzalez-Moles MA, Esteban F, Rodriguez-Archilla A, Ruiz-Avila I, Gonzalez-Moles S. Importance of tumour thickness measurement in prognosis of tongue cancer. Oral Oncol. 2002 Jun;38(4):394-7. doi: 10.1016/s1368-8375(01)00081-1.
PubMed 12076706Huang SF, Kang CJ, Lin CY, Fan KH, Yen TC, Wang HM, Chen IH, Liao CT, Cheng AJ, Chang JT. Neck treatment of patients with early stage oral tongue cancer: comparison between observation, supraomohyoid dissection, and extended dissection. Cancer. 2008 Mar 1;112(5):1066-75. doi: 10.1002/cncr.23278.
PubMed 18246535Shim SJ, Cha J, Koom WS, Kim GE, Lee CG, Choi EC, Keum KC. Clinical outcomes for T1-2N0-1 oral tongue cancer patients underwent surgery with and without postoperative radiotherapy. Radiat Oncol. 2010 May 27;5:43. doi: 10.1186/1748-717X-5-43.
PubMed 20504371Caramello P, Giacobbi D, Savoia D. [Identification of Pneumocystis carinii in a patient dying of AIDS]. G Batteriol Virol Immunol. 1985 Jul-Dec;78(7-12):171-7. Italian.
PubMed 3879892
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST)
- ClinicalTrials.gov ID
- NCT03853655
- Acronym / sponsor ID
- AREST / 1713
- Conditions
- Cancer of Mouth, Cancer of the Tongue, Cancer of the Head and Neck, Buccal Mucosa Cancer, Floor of Mouth Carcinoma
- Keywords
- Cancer of the Mouth, Tongue cancer, Buccal Mucosa cancer, Head and Neck, Oral Cancer, Adjuvant Radiotherapy, Depth of Invasion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- NATIONAL CANCER GRID
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 25 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.
This study will assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having tumor thickness more than or equal to 5mm. The study population will consist of patients who have been treated by surgery for early stage oral tongue cancers. Patients with a close or positive margin (</= 5mm) and or with metastatic neck node(s) will be excluded. Selected patients will be randomized into two groups. The group I will be observed after surgery and group II will receive adjuvant radiotherapy as per protocol.
Detailed description
The aim of this study is to assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having a tumor depth of invasion more than or equal to 5mm.
Primary objective:
To determine the impact of postoperative adjuvant radiotherapy on locoregional recurrence-free survival in patients with early-stage oral tongue cancer with tumor thickness ≥ 5 mm.
Secondary objectives:
- To compare disease-free survival and overall survival between the two groups.
- To assess and compare the quality of life changes between the two groups.
- To assess the acute and long-term radiation toxicity.
We will be conducting a Phase III Open-Label Prospective Randomized Controlled Trial using stratified randomization. Patients will be randomized into two groups:
Group I: Control arm (Observation only) Group II: Study arm (Postoperative adjuvant radiotherapy)
Patients will be stratified on the following factors
- Presence of Perineural Invasion (PNI)/Lympho-Vascular Emboli (LVE)
- Histological grade (well-differentiated/moderately differentiated vs poorly differentiated)
- Tongue/Floor of Mouth vs Buccal Mucosa.
Study procedures:
The study population will consist of patients who have been treated by surgery for early-stage oral cancers. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. The depth of invasion will be assessed microscopically by measuring the maximum vertical bulk of the tumor from the normal mucosal surface to the deepest point of invasion. After reviewing the histopathological report, patients will be randomized to one of the 2 arms. Patients belonging to study arm (Group II) will receive adjuvant radiotherapy 60 Gray, 30 fractions for 30 days over 6 weeks as routinely prescribed at Tata Memorial Center (TMC) and will receive the treatment within or by 6 weeks after surgery.
Both the groups (Group I and Group II) will be under regular follow-up with 3 monthly intervals for the first 2 years and 6 monthly for the next 3 years and once a year thereafter. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of randomization and the date of biopsy-proven recurrence. We will also record the overall survival in both groups. The quality of life will be assessed at each follow-up regular intervals using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ H\&N-35 ) and EORTC QLQ-C 30. The radiation toxicity will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patients in this arm will be observed and kept under active follow-up after surgery for the primary. |
| Study arm | Experimental | Radiation: Post-operative adjuvant radiotherapyIntervention in the study arm will be in the form of post-operative adjuvant radiotherapy starting within 6-weeks after primary surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Post-operative early stage squamous cell carcinoma of the oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth). (pT1, pT2, N0 as defined in the AJCC Classification 8th edition.
- Adequate surgery (Defined as wide local excision of the primary tumor with tumor-free margin ≥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.)
- Written informed consent.
- Age ≥18 years
- Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2
Key exclusion criteria (8 listed)
- pT3/pT4 (as specified in the AJCC 8th edition).
- Depth of invasion < 5mm.
- Any neck nodal metastasis with or without extra nodal extension
- Tumor-free margin < 5 mm
- Non-squamous histology
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 |
|---|---|---|
| Post-operative adjuvant radiotherapyConventional treatment planning, as well as intensity-modulated radiation therapy (IMRT) planning, would be allowed on the study with patients being stratified on the RT technique. Treatment would be delivered on telecobalt unit (gamma-rays/linear accelerator (6MV photons). All fields would be treated daily. Phase I: 46 Gray(Gy) in 23 fractions over 4.5 weeks Phase II: 14Gray in 7 fractions over 1.5 weeks For IMRT, inverse planning would be done on a commercial TPS configured to deliver IMRT using 6MV photons. Patients shall be treated using the simultaneous integrated boost (SIB) technique with 5 fractions being delivered every week. | Radiation | Study arm |
Primary outcome
loco-regional recurrence free survival
Time frame: Date of randomization to loco regional recurrence (date of proven biopsy date) or at the end of 36 months after recruitment of the last participant.
Measures the number of local or regional recurrences in both arm over a defined time frame.
2 secondary outcomes
Disease free survival
Time frame: Calculated as difference of date of randomization to date of first documented recurrence or relapse, second primary or death or at the end of 36 months after recruitment of the last participant.
Overall survival
Time frame: Date of randomization to death from any cause or at the end of 36 months after recruitment of the last participant.
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 16 Jan 2026.
- Background: PubMed 24619660Thiagarajan S, Nair S, Nair D, Chaturvedi P, Kane SV, Agarwal JP, D'Cruz AK. Predictors of prognosis for squamous cell carcinoma of oral tongue. J Surg Oncol. 2014 Jun;109(7):639-44. doi: 10.1002/jso.23583. Epub 2014 Mar 12.
- Background: PubMed 11845040Dequanter D, Saint-Aubin N, Paesmans M, Badr-El-Din A, Lothaire P, Andry G. [Prognostic factors in epidermoid carcinoma of the mobile tongue classified as T1-T2]. Ann Otolaryngol Chir Cervicofac. 2001 Oct;118(5):315-22. French.
- Background: PubMed 21600000Kokemueller H, Rana M, Rublack J, Eckardt A, Tavassol F, Schumann P, Lindhorst D, Ruecker M, Gellrich NC. The Hannover experience: surgical treatment of tongue cancer--a clinical retrospective evaluation over a 30 years period. Head Neck Oncol. 2011 May 21;3:27. doi: 10.1186/1758-3284-3-27.
- Background: PubMed 21717431Ganly I, Patel S, Shah J. Early stage squamous cell cancer of the oral tongue--clinicopathologic features affecting outcome. Cancer. 2012 Jan 1;118(1):101-11. doi: 10.1002/cncr.26229. Epub 2011 Jun 29.
- Background: PubMed 12076706Gonzalez-Moles MA, Esteban F, Rodriguez-Archilla A, Ruiz-Avila I, Gonzalez-Moles S. Importance of tumour thickness measurement in prognosis of tongue cancer. Oral Oncol. 2002 Jun;38(4):394-7. doi: 10.1016/s1368-8375(01)00081-1.
- Background: PubMed 18246535Huang SF, Kang CJ, Lin CY, Fan KH, Yen TC, Wang HM, Chen IH, Liao CT, Cheng AJ, Chang JT. Neck treatment of patients with early stage oral tongue cancer: comparison between observation, supraomohyoid dissection, and extended dissection. Cancer. 2008 Mar 1;112(5):1066-75. doi: 10.1002/cncr.23278.
- Background: PubMed 20504371Shim SJ, Cha J, Koom WS, Kim GE, Lee CG, Choi EC, Keum KC. Clinical outcomes for T1-2N0-1 oral tongue cancer patients underwent surgery with and without postoperative radiotherapy. Radiat Oncol. 2010 May 27;5:43. doi: 10.1186/1748-717X-5-43.
- Background: PubMed 3879892Caramello P, Giacobbi D, Savoia D. [Identification of Pneumocystis carinii in a patient dying of AIDS]. G Batteriol Virol Immunol. 1985 Jul-Dec;78(7-12):171-7. Italian.
- SEER Cancer statistics review 1975-2010. National cancer instituteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Sudhir V Nair, MS, MCh principal investigator
Associate Professor
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative adjuvant radiotherapy in people with Cancer of Mouth and Cancer of the Tongue, run by Tata Memorial Hospital at 8 sites 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 8 inclusion and 8 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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?
loco-regional recurrence free survival (time frame: Date of randomization to loco regional recurrence (date of proven biopsy date) or at the end of 36 months after recruitment of the last participant.). 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 NCT03853655, which also lists 8 linked publications.
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 16 Jan 2026.