Cancer of the Head and Neck Clinical Trial
— ARESTOfficial title:
Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST)
Verified date | April 2024 |
Source | Tata Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 392 |
Est. completion date | September 30, 2026 |
Est. primary completion date | August 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | HCG Hospital | Ahmedabad | Gujarat |
India | Mazumdar Shaw Medical Centre | Bangalore | Karnataka |
India | Sree Sankara Cancer Hospital | Bangalore | Karnataka |
India | Kailash Cancer Hospital and Research Centre | Goraj | Gujarat |
India | Dr. B Barooah Cancer Institute | Guwahati | Assam |
India | Malabar Cancer Centre | Kannur | Kerala |
India | Amrita Institute of Medical Sciences | Kochi | Kerala |
India | Tata Memorial Centre | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Hospital | NATIONAL CANCER GRID |
India,
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Dequanter 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. — View Citation
Ganly 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. — View Citation
Gonzalez-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. — View Citation
Huang 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. — View Citation
Kokemueller 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. — View Citation
Shim 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life Measurement | Measured using EORTC QLQ H&N-35 and EORTC QLQ-C 30 | at Randomization, 3 months after completion of all treatments, 1 year, 2 years and 3 years after completion of all treatments. | |
Other | Acute and long-term Radiation toxicity rate | The Common Terminology Criteria for Adverse Events (CTCAE V 4.0) will be used for assessing the Adverse events. The Radiation Therapy Oncology Group (RTOG) acute and late radiation morbidity scoring criteria will be used for assessing the radiotherapy related toxicity. | From the date of randomization until the date of first documented disease recurrence or date of death from any cause, assessed up to 36 months. | |
Primary | loco-regional recurrence free survival | Measures the number of local or regional recurrences in both arm over a defined 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. | |
Secondary | Disease free survival | time from the beginning of an intervention until patient experiences a recurrence, a new primary cancer or death. | 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. | |
Secondary | Overall survival | Date of Randomization to death from any cause | Date of randomization to death from any cause or at the end of 36 months after recruitment of the last participant. |
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