Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread (ExtentN1)
Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking.
The ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm.
The primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities.
This trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.
調査の概要
状態
条件
詳細な説明
Cervical lymph node metastasis is the most important prognostic factor in oral cavity squamous cell carcinoma (OCSCC). Surgical management of the neck is an integral component of treatment; however, the optimal extent of neck dissection for patients with clinically node-positive (cN1) disease remains uncertain. Although modified neck dissection (levels I-V with preservation of non-lymphatic structures) has traditionally been recommended for node-positive disease, several retrospective studies have suggested that carefully selected patients with limited nodal disease may achieve comparable regional control with a less extensive selective neck dissection. Nevertheless, these studies are subject to selection bias, and no adequately powered randomized controlled trial has directly compared these surgical approaches.
Dissection of lower cervical nodal levels may increase operative time and postoperative morbidity, including shoulder dysfunction, sensory deficits, chyle leak, and impairment in quality of life. Reducing the extent of neck dissection without compromising oncologic outcomes could improve postoperative functional recovery and patient-reported outcomes while maintaining regional disease control.
The ExteNT N1 Trial is designed to address this evidence gap by comparing selective neck dissection (levels I-IV) with modified neck dissection (levels I-V) in patients with resectable cN1 OCSCC. In addition to evaluating oncologic outcomes, the study incorporates validated functional and quality-of-life assessments to comprehensively evaluate the impact of the two surgical strategies. Participants will receive standard treatment for the primary tumor, and adjuvant therapy will be administered according to final histopathological findings and contemporary treatment guidelines.
The findings of this trial are expected to provide high-level evidence to guide the surgical management of the clinically N1 neck in OCSCC. If selective neck dissection demonstrates equivalent oncologic outcomes with lower morbidity, it may support a change in surgical practice by reducing unnecessary treatment while preserving function and quality of life.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Maroti B Wadewale, MDS, FHNO
- 電話番号：+918483851334
- メール：dr.marotiwadewale59@gmail.com
研究連絡先のバックアップ
- 名前：Parag J Watve, MS, FHNS
- 電話番号：+919823109918
- メール：paragwatve@kolhapurcancercentre.com
研究場所
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Maharashtra
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Kolhāpur、Maharashtra、インド、416004
- 募集
- Kolhapur Cancer Centre
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コンタクト：
- Maroti B Wadewale, MDS, FHNO
- 電話番号：+918483851334
- メール：dr.marotiwadewale59@gmail.com
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コンタクト：
- Yogesh Anap, MD
- 電話番号：+919867155930
- メール：yogesh.anap1@gmail.com
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主任研究者：
- Maroti B Wadewale, MDS, FHNO
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副調査官：
- Parag Watve, MS, FHNS
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of oral cavity will be included
- Clinical stage T1-T4, N1, M0
- cN1 neck on clinical examination and imaging (CT/MRI)
- Single node which is FNAC proven without any other significant nodes.
- Patients with ASA grade II and I.
- Understands the protocol and able to give informed consent.
Exclusion Criteria:
- Recurrent cases
- Multiple significant nodes
- Nodes clinical/radiological with ENE
- Single metastatic node at level III/IV/V
- Single metastatic node with other suspicious nodes
- Patients with a history of head and neck radiation therapy treatment
- Previous history of any malignancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Arm 1- Selective neck dissection level I to level IV
Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral selective neck dissection involving cervical lymph node levels I-IV.
Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.
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Selective neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, and IV on the ipsilateral side while preserving uninvolved non-lymphatic structures.
The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required.
Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.
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アクティブコンパレータ：Arm 2- Modified Neck Dissection (Levels I-V)
Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral modified neck dissection involving cervical lymph node levels I-V while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate.
Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.
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Modified neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, IV, and V on the ipsilateral side while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate.
The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required.
Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Regional Recurrence-Free Survival (RRFS)
時間枠：3 years after surgery
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Regional recurrence-free survival is defined as the time from the date of definitive surgery to the first documented regional recurrence in the cervical lymph nodes or death from any cause, whichever occurs first.
Regional recurrence will be confirmed by clinical examination, imaging, and histopathological evaluation whenever feasible.
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3 years after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival (OS)
時間枠：Up to 3 years after surgery
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Overall survival is defined as the time from definitive surgery until death from any cause.
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Up to 3 years after surgery
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Disease-Free Survival (DFS)
時間枠：Up to 3 years after surgery
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Disease-free survival is defined as the time from definitive surgery to the first documented local, regional, or distant recurrence, or death from any cause.
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Up to 3 years after surgery
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Level-wise Cervical Lymph Node Metastasis
時間枠：At the time of surgery (histopathological examination)
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Distribution of histopathologically confirmed metastatic lymph nodes according to cervical nodal level.
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At the time of surgery (histopathological examination)
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Nodal Yield
時間枠：At the time of surgery
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Total number of lymph nodes retrieved during neck dissection and confirmed by histopathological examination.
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At the time of surgery
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Shoulder Function assesment
時間枠：Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
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Shoulder function will be assessed using the Constant-Murley Score (0-100 points), with higher scores indicating better shoulder function.
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Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
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Postoperative Surgical Morbidity
時間枠：Within 30 days after surgery
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Incidence of postoperative complications, including chyle leak, hematoma, wound infection, seroma, cranial nerve injury
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Within 30 days after surgery
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Shoulder function assesment with Shoulder pain and disability index
時間枠：Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery
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Shoulder pain and disability will be assessed using theShoulder pain and disability index questionnaire.
Scores range from 0 to 100, with higher scores indicating greater pain and disability.
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Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Pantvaidya GH, Pal P, Vaidya AD, Pai PS, D'Cruz AK. Prospective study of 583 neck dissections in oral cancers: implications for clinical practice. Head Neck. 2014 Oct;36(10):1503-7. doi: 10.1002/hed.23494. Epub 2014 Jan 13.
- Liang L, Zhang T, Kong Q, Liang J, Liao G. A meta-analysis on selective versus comprehensive neck dissection in oral squamous cell carcinoma patients with clinically node-positive neck. Oral Oncol. 2015 Dec;51(12):1076-81. doi: 10.1016/j.oraloncology.2015.10.005. Epub 2015 Oct 23.
- Hashmi SS, Abbas A, Bukhari A, Saeed J, Shafqat A, Siddique AH, Buksh AR, Murtaza G. Selective Neck Dissection for Node-Positive Oral Cavity Squamous Cell Carcinoma: A Retrospective Cohort Study. Int Arch Otorhinolaryngol. 2022 Feb 22;26(4):e630-e635. doi: 10.1055/s-0041-1741437. eCollection 2022 Oct.
- Shin YS, Koh YW, Kim SH, Choi EC. Selective neck dissection for clinically node-positive oral cavity squamous cell carcinoma. Yonsei Med J. 2013 Jan 1;54(1):139-44. doi: 10.3349/ymj.2013.54.1.139.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ExteNTN1
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IPD プランの説明
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