Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Laryngeal Diseases

Laryngeal Cancer

Transoral CO2 laser supraglottic laryngectomy and irradiation

CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed

laser surgery

200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery

radiation therapy

Roy K. Davis, MD

RATIONALE: Laser surgery for cancer of the larynx may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy and laser surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx.

OBJECTIVES: I. Assess the feasibility of treating untreated stage I, II and selected stage III squamous cell carcinoma of the supraglottic larynx with endoscopic surgery and irradiation. II. Estimate the 3 year progression free survival and describe the location of disease progression.

OUTLINE: Patients receive carbon dioxide laser laryngectomy within 28 days following protocol registration. Patients with N1 disease may undergo an optional neck dissection ipsilateral to the neck mass. Neck dissection includes complete removal of at least lymph node levels 2-4. Radiation therapy begins 14 days following laser surgery. Patients are followed every 3 months for the first year, every 6 months for the second year, and every 12 months thereafter until death.

PROJECTED ACCRUAL: There will be 50 patients accrued into this study in 3 years with an estimated accrual rate of 20 patients per year.

S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx

A Phase II Study to Evaluate Transoral CO2 Laser Supraglottic Laryngectomy and Irradiation in Stage I, II and III Squamous Cell Carcinoma of the Supraglottic Larynx

To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).

From date of registration to date of first observation of progressive disease, death due to any cause or early discontinuation of treatment

how long patients require feeding tubes and the proportion of patients requiring tracheostomy

National Cancer Institute (NCI)

SWOG Cancer Research Network

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Cervical Neoplasms

Vaginal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients with HPV-related disease including cervical and vaginal lesions

Patients will have laser surgery for managing HPV-related lesions

LASER surgery

Giorgio Bogani

In the recent years, the widespread adoption of primary and secondary preventions has dramatically reduced the incidence of cervical cancer in developed countries. However, cervical cancer still represents a major health concern, being the third most common malignancy among women aged \<39 years, and the second most common cause of death for cancer among females between 20 and 39 years in the United States.

Cervical cancer is one of the most preventable types of cancer, since it develops over a long time and the causative agent has been recognized. Persistent infection from human papillomavirus (HPV) is the main factor causing cervical cancer. Generally, persistent HPV infection causes cervical dysplasia (also known as cervical intraepithelial neoplasia), which potentially evolves in cancer. Although the majority of women with HPV infection will never develop lesions, a relatively high number of women is at risk of developing cervical dysplasia. Women with cervical dysplasia who have appropriate follow-up and treatments are at low risk of developing cervical cancer. However, recurrent cervical dysplasia is a well-known risk factor for cervical cancer. Additionally, recurrent cervical dysplasia might be cause of morbidity since adjunctive surgical treatments are associated with fertility and obstetrical issues in women who wish to preserve their childbearing potential. With this background, identifying the best treatment modality for patients with cervical dysplasia is of paramount importance.

However, the management of residual/recurrent dysplasia after primary treatment is often challenging. Moreover, it is important to classify patients based on their risk of having persistent/recurrent dysplasia after primary treatment. Assessing these classes of risks is useful in tailoring appropriate surveillance and determining the need for adjunctive treatments. Our study group estimated the risk of developing persistent/recurrent dysplasia in several investigations, observing that positive surgical margins, surgical techniques, high-risk HPV infection at the time of diagnosis, and HPV persistence are the main prognostic factors. Our data corroborated a considerable body of literature investigating this issue. However, it is difficult to estimate the risk of developing persistent/recurrent dysplasia for each patient.

Similarly, few investigations evaluated outcomes of patientsaffected by vaginal intraepithelial neoplasia with discor-dant results. In fact, there is no consensus on the optimaltreatment modality for those patients. Treatments in-cluded: topical application of imiquimod or 5-fluorouracil(5-FU), as well as ablative and excisional proceduresexecuted via conventional surgery, electrosurgery andcarbon dioxide LASER. The risk of developinginvasive vaginal cancer in those patients remains unclear,ranging between 2% and 12% in different series.Recently, a multi-institutional Italian study reports thatmore than 10% of women initially diagnosed with high-grade vaginal intraepithelial neoplasia are detected withoccult invasive vaginal cancer at the time of excisionalprocedure, thus suggesting the need to achieve a histologi-cal diagnosis before proceeding to ablative or medicaltreatments Here, we aim to evaluate the importance of various prognostic factors in influencing the risk of persistent/recurrent lesions of the uterine cervix and the vagina

Treatments of HPV-related Lesions

Predictors of Recurrence After Treatment of HPV-related Disease

time between surgery and first recurrence

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Diseases and Abnormalities at or Before Birth

Renal Insufficiency

Carcinoma, Transitional Cell

Solitary Kidney

Kidney Neoplasms

Ureteral Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Urologic Neoplasms

Urogenital Neoplasms

Ureteral Diseases

Congenital Abnormalities

Urogenital Abnormalities

Pathological Conditions, Anatomical

Transitional Cell Carcinoma

Transitional Cell Cancer of the Renal Pelvis and Ureter

All Drugs and Chemicals

Disitamab vedotin

DV, 2.0 mg/kg, intravenously administered every 2 weeks; toripalimab, 3.0mg/kg, intravenously administered every 2 weeks;

2.0 mg/kg, intravenously administered every 2 weeks

3.0mg/kg, intravenously administered every 2 weeks

Toripalimab

Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy.

Laser surgery

Dingwei Ye, Doctor

Hailiang Zhang, Doctor

dingwei ye

Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment.

DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC

A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple Upper Urinary Tract Urothelial Carcinoma

Defined as the time to systemic relapse or death.

Defined as the time to systemic progression or death.

Defined by time from day of first treatment to RNU.

Defined by time from day of first treatment to death due to a specific disease, reflecting the clinical benefit of a specific disease.

Defined by time from day of first treatment to death.

Fudan University

Principal Investigator

endoscopic surgery

Martin A. Birchall, MD

RATIONALE: Endoscopic surgery is a less invasive type of surgery for laryngeal cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether endoscopic surgery is more effective than radiation therapy in treating laryngeal cancer of the glottis.

PURPOSE: This randomized phase II trial is studying endoscopic surgery to see how well it works compared with radiation therapy in treating patients with stage 0, stage I, or stage II laryngeal cancer of the glottis.

OBJECTIVES:

* Determine the feasibility of conducting a large phase III randomized study in the future, comparing radiotherapy vs endoscopic excision in patients with stage 0-II laryngeal cancer of the glottis.
* Determine patient acceptability of the proposed trial design.
* Compare the effect of using dedicated head and neck research nurses vs general nurses on patient recruitment.
* Refine outcome measures, including voice analysis and quality of life.

OUTLINE: This is a randomized, controlled, multicenter, pilot study. Patients are stratified according to participating center and T stage (Tis or T1 vs T2a). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo endoscopic excision via CO_2 laser or cold steel.
* Arm II: Patients undergo radiotherapy once daily, 5 days a week, for 3-4 weeks. Patients undergo vocal analysis at baseline and at 6 months and 1 and 2 years after randomization.

Quality of life is assessed at baseline, at 1 year, and then annually for 5 years.

After completion of study treatment, patients are followed periodically for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx	NCT00003040	Head and Neck C...	laser surgery radiation thera...	18 Years -	SWOG Cancer Research Network
Treatments of HPV-related Lesions	NCT05938192	HPV Cervical Cancer Cervix Lesion Vagina Disease	LASER surgery	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx	NCT00003040	Head and Neck C...	laser surgery radiation thera...	18 Years -	SWOG Cancer Research Network
DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC	NCT06354231	Renal Insuffici... Upper Urinary T... Solitary Kidney	DV Toripalimab Laser surgery	18 Years -	Fudan University
Treatments of HPV-related Lesions	NCT05938192	HPV Cervical Cancer Cervix Lesion Vagina Disease	LASER surgery	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Endoscopic Surgery or Radiation Therapy in Treating Patients With Stage 0, Stage I, or Stage II Laryngeal Cancer of the Glottis	NCT00334997	Head and Neck C...	endoscopic surg... laser surgery radiation thera...	18 Years -	National Cancer Institute (NCI)
S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx	NCT00003040	Head and Neck C...	laser surgery radiation thera...	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for laser surgery