Clinical trial · Interventional
Adjuvant Radiotherapy in Early Stage Oral Cancers
Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST)
NCT03853655CI-TRIAL-00101084ARESTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Buccal Mucosa Cancer | — | UNRESOLVED | — |
| Cancer of Mouth | Oral Cavity Carcinoma | ALIAS | 0.90 |
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Cancer of the Tongue | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
| Floor of Mouth Carcinoma | Floor of the Mouth Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative adjuvant radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Patients in this arm will be observed and kept under active follow-up after surgery for the primary.
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Intervention in the study arm will be in the form of post-operative adjuvant radiotherapy starting within 6-weeks after primary surgery.
- interventionNames
- Radiation: Post-operative adjuvant radiotherapy
Primary outcomes (1)
- measure
- loco-regional recurrence free survival
- timeFrame
- 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.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. 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.) 3. Written informed consent. 4. Age ≥18 years 5. Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2 6. The depth of invasion (DOI) ≥ 5 mm. 7. Compliance to therapy and follow-up 8. The interval from surgery to adjuvant radiotherapy ≤ 6 weeks Exclusion Criteria: 1. pT3/pT4 (as specified in the AJCC 8th edition). 2. Depth of invasion \< 5mm. 3. Any neck nodal metastasis with or without extra nodal extension 4. Tumor-free margin \< 5 mm 5. Non-squamous histology 6. Pregnant woman 7. Prior h/o any other malignancy in the last five years 8. Prior therapeutic irradiation of the head and neck.
References
Publications (8)
- BACKGROUNDThiagarajan 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. PMID 24619660
- BACKGROUNDDequanter 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. PMID 11845040
- BACKGROUNDKokemueller 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. PMID 21600000
- BACKGROUNDGanly 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. PMID 21717431
- BACKGROUNDGonzalez-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. PMID 12076706
- BACKGROUNDHuang 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. PMID 18246535
- BACKGROUNDShim 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.