跳至主要内容
临床试验/CTRI/2024/04/065397
CTRI/2024/04/065397
招募中
1/2 期

Phase I study to assess the safety of hyperthermic intracavitary chemotherapy in advanced oral cavity cancer

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年4月22日最近更新:

概览

阶段
1/2 期
状态
招募中
入组人数
12
试验地点
1
主要终点
Dose Limiting Toxicities (DLTs) from the procedure

概览

简要总结

Head and neck cancer is the third most common cancer in the Indian subcontinent with oral cavity subsite being the most affected.A large number of cases report at an advanced stage (Stage III and IV). These advanced cancer patients have a higher incidence of disease returning early, even after completing the currently prescribed treatment. This has found to affect longevity and quality of life. Various treatments have been researched in an effort to prolong life in these advanced cancer patients. Moreover, with the presence of certain disease characteristics like tumours spreading into its surroundings, can affect the chances of the disease coming back again very soon. To overcome this, treatments such as chemotherapy before surgery have shown promise but can only be given up to a limited dosage via intravenous route to avoid drastic side effects. Despite this, the longevity after treatment is poor and a lot of unanswered questions remain in the treatment of these advanced cases. These issues are also present in cancers of other sites. To tackle these issues clinicians dealing with abdomen, chest and bladder cancers, a treatment involving using circulated, heated chemotherapy in the cavity has shown promising results. This is a kind of “wash” given into the cavity so that tumour cells are killed locally without any systemic side effects. In this way, the chemotherapy can be used in higher doses at the site of the cancer, without the side effects noted in the intravenous route. While this is standard practice for cancers in other places, it has not been tried in the head and neck. This study is a pilot of 12 individuals that will assess the safety and help determine a safe dose of using this method for oral cavity cancers.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Ability to understand the procedure and willingness to sign an informed consent
  • ECOG Performance Status 2
  • Age 18 years old, up to 65 years old
  • Histopathology proven diagnosis of squamous cell carcinoma
  • Surgically resectable Stage III/IV oral cancer, as per the multidisciplinary discussion
  • Primary tumor should be lateralised so as to not require bilateral neck dissection
  • Nodal disease with/without extranodal extension on clinical examination/imaging
  • No distant metastases below the clavicles, based upon the following minimum diagnostic workup: a.
  • History/physical examination by the physician b.
  • Imaging of the head and neck (Contrast enhanced MRI for local workup and Chest CT/PET-CT for distant metastatic workup)

排除标准

  • History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel
  • Prior invasive malignancy, unless disease free for a minimum of 3 years, with the exception of radically excised basal cell
  • Prior chemotherapy for a different cancer administered within 3 years prior to registration
  • Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields
  • Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base
  • Calculated GFR less 50 cc/min
  • Patients who have uncontrolled cardiac comorbidity
  • Presence of severe malnutrition
  • Severe active co-morbidities
  • Radiographic evidence of retropharyngeal and or level VI metastasis

结局指标

主要结局

Dose Limiting Toxicities (DLTs) from the procedure

时间窗: At baseline; 30 days post-surgery; at 1 year

次要结局

  • 1. To determine patterns of locoregional failure and survival outcomes(2 year)
  • 2. To determine the compliance for treatment options(immediate)
  • 3. To determine distribution of HICOC in systemic circulation(upto day 2)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Arjun Singh

TATA MEMORIAL CENTRE

研究点 (1)

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