NCT06702033招募中2 期
Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial-2 (MINT-2)"
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- Recurrence rate
研究概览
简要总结
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy.
However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate.
In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to:
- Arm 1 (de-POACRT-42 Gy)
- Arm 2A (de-POART-42 Gy)
- Arm 2B (de-POART-37.8 Gy)
- Arm 2C (de-POACRT-30 Gy).
All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded. HPV-related may be defined by p16 IHC stain and/or HPV-High Risk RNA ISH/HPV DNA genotyping by PCR, using standard definitions of positive and negative test results.
- •Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).
- •Planned unilateral or contralateral selective neck dissection.
- •ECOG PS 0-
- •Adequate organ and marrow function defined as:
- •Creatinine clearance ≥ 50 mL/min.
- •ANC ≥ 1.0 K/cumm.
- •Platelet count ≥100 K/cumm.
- •At least 18 years of age.
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
排除标准
- •Clinical T1N0M0 or T2N0M0 disease.
- •Prior radiation therapy for HNSCC.
- •Planned free-flap reconstruction of the resected primary site.
- •Cirrhosis with Child-Pugh Score B or C.
- •History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year OS > 90%) that were treated with curative-intent therapy.
- •Receiving any other investigational agents.
- •Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant and/or breastfeeding. A negative serum pregnancy test is required at screening for all female patients of childbearing potential.
研究组 & 干预措施
Arm 1: Radiation therapy + Cisplatin
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
- Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
干预措施: Radiation therapy (Radiation)
Arm 1: Radiation therapy + Cisplatin
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
- Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
干预措施: Surgery (Procedure)
Arm 2C: Radiation therapy + Cisplatin
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each.
- Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
干预措施: Surgery (Procedure)
Arm 2C: Radiation therapy + Cisplatin
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each.
- Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
干预措施: Cisplatin (Drug)
Arm 1: Radiation therapy + Cisplatin
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
- Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
干预措施: Cisplatin (Drug)
Arm 2A: Radiation therapy
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
干预措施: Radiation therapy (Radiation)
Arm 2A: Radiation therapy
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
干预措施: Surgery (Procedure)
Arm 2B: Radiation therapy
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 3780 cGY in 21 fractions of 180 cGy each over 4 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3360 cGy in 21 fractions of 160 cGy each.
干预措施: Radiation therapy (Radiation)
Arm 2B: Radiation therapy
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 3780 cGY in 21 fractions of 180 cGy each over 4 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3360 cGy in 21 fractions of 160 cGy each.
干预措施: Surgery (Procedure)
Arm 2C: Radiation therapy + Cisplatin
Experimental
- Standard of care surgery will occur before adjuvant therapy.
- It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
- The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks.
- Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each.
- Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Recurrence rate
时间窗: At 2 years
次要结局
- Percent weight loss(From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks))
- Proportion of patients undergoing PEG tube placement(Through completion of follow-up (estimated to be 5 years and 10 weeks))
- Duration of need for an indwelling PEG tube(Through completion of follow-up (estimated to be 5 years and 10 weeks))
- Proportion of patients taking narcotic(Through completion of follow-up (estimated to be 5 years and 10 weeks))
- Number of participants with adverse events(From start of surgery through 24-month follow-up visit (estimated to be 2 years and 10 weeks))
- Mean change in serum creatinine during radiation therapy(From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks))
- Progression-free survival (PFS)(Through completion of follow-up (estimated to be 5 years and 10 weeks))
- Overall survival (OS)(Through completion of follow-up (estimated to be 5 years and 10 weeks))
研究者
研究点 (3)
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