Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Standard conventional Treatment Arm, IGRT

Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Adaptive Radiotherapy

Maja Guberina, PD Dr. med. (MD), specialist

Ina Grübel

Maja Guberina, PD Dr. med. (MD)

Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.

Online-adaptive radiotherapy (ART) makes it possible to adapt the dose distribution to the anatomical changes online immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard in radiotherapy. Here, a cone-beam CT (CBCT) is also performed at the beginning of each fraction, which is used to position the patients in relation to the radiation field arrangement of the initial radiation plan approved for the series. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations in the body from radiation fraction to radiation fraction, e.g. due to different rectum and bladder fillings.

In ART mode, the online adaptive treatment plan for the current treatment is then selected and approved by the specialist online onboard in all cases in which the current target volume for the tumor expansion is not sufficiently covered by the initial treatment plan pre-planned for the series with its planned tolerances, or surrounding normal tissue is exposed too much. If the ART plan does not show any clear dosimetric advantages over the reference plan, especially if the initial plan covers the target volume of the day well, there are no dose increases and the normal tissues are spared as intended, the initial radiation plan from the planning CT can also be used as in IGRT. The aim of this study is to treat at least 15 patients with locally advanced gynecological carcinoma (mainly cervical carcinoma, endometrial carcinoma, vaginal carcinoma), who are to receive definitive radiotherapy at the Department for Radiotherapy at the University Hospital Essen, in ART mode on the Ethos therapy device over an initial 10 radiation fractions. The dose distribution is always compared with the adaptive and the initial plan for the radiation series on the anatomy of the day by the specialist and medical physics expert. The aim of this study is to prospectively investigate what percentage of patients benefit from ART when using standard PTV margins and how to recognize the corresponding patients early in the series. Secondarily, it will be investigated in what proportion of patients the risk organ burden and the safety margins around the clinical target volume can be reduced with ART compared to IGRT and how large this reduction can be.

The EORTC and CTC AE toxicitiy scales and further assessment scales will be evaluated in order to quantify objective and subjective side effects.

Adaptive Radiotherapy in Patients With Gynecological Tumors

Prospective Randomized Validation of Adaptive Radiotherapy in Patients With Gynecological Tumors and Indication for Radiotherapy

Rectum, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Bladder, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Skin, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Lymph-Edema, EORTC CTC-AE ( (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-3, \[score 1: nearly no toxicity, asymptomatic changes - score 3: worst outcome, severe symptoms; limiting self care ADL\]

University Hospital, Essen

PD Dr. med. (MD) M. Guberina (senior consultant, specialist)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

Analgesics

All Drugs and Chemicals

Interleukin-2

C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2)

C-TIL052A injection followed by injection of IL-2

Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection

Xiaohua Wu, MD, Ph.D

Jian Zhang, MD, Ph.D

A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.

For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.

Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

A Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer

To characterize the safety profile and evaluate tolerability of C-TIL052A cell therapy by collecting, analyzing the treatment emergent adverse events (TEAEs) and adverse events of special interest (AESIs) during and post treatment, especially the incidence and severity of adverse events (AE) within 28 days post TIL infusion.

Proportion of patients with response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Proportion of patients ever comfirmed with response or stable disease (CR+PR+SD) during the follow-up period per RECIST v1.1

The time length between the first confirmed objective response to the treatment and the subsequent disease progression per RECIST 1.1

The time length between TIL infusion and confirmed subsequent disease progression per RECIST 1.1

The time length of patients living from the date of TIL infusion

The time length of patients living without progression from the date of TIL infusion

Cellular Biomedicine Group Ltd.

Fudan University

Professer

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Dexamethasone

Ondansetron

Aprepitant

Dexamethasone acetate

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

Placebo 130mg iv d1 30min d1 before chemotherapy (IV time \&gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy; Dexamethasone 12mg iv once d1 before chemotherapy 30min, dexamethasone 8mg po qd d2 \~ 4.

Aprepitant injection 130mg iv d1 30min d1 before chemotherapy (push-back time \&gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy;Dexamethasone 12mg iv once d1 30min before chemotherapy, 8mg po qd d2-4.

Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups use Aprepitant,Dexamethasone and Ondansetron.

Aprepitant Injection

Dengfeng Wang

Wang Dengfeng, Doctor

To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor.

The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently no prevention of TC in patients with gynecological malignant tumors High-level evidence-based medical evidence for programme-induced CINV. Therefore, different guidelines recommend the best antiemetic regimen as well It's different. This study is intended to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The designed Phase III clinical study provides important data and basis for clinical practice and guideline formulation.

Patients, nurses, and investigators were blinded.

Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients

A Randomized, Double-blind, Placebo-controlled Clinical Study on Prevention and Treatment of CINV Induced by TC Regimen in Gynecological Malignant Tumors

CR is defined as a patient who does not need rescue antiemesis treatment, no vomiting or retching.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adaptive Radiotherapy in Patients With Gynecological Tumors	NCT06230549	Gynecological T... Adaptive Radiot... Radiation Curative Treatm... Optimization Adaptive Radiat... Image Guided Ra... Cervical Carcin...	Adaptive Radiot...	18 Years -	University Hospital, Essen
Adaptive Radiotherapy in Patients With Gynecological Tumors	NCT06230549	Gynecological T... Adaptive Radiot... Radiation Curative Treatm... Optimization Adaptive Radiat... Image Guided Ra... Cervical Carcin...	Adaptive Radiot...	18 Years -	University Hospital, Essen
Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer	NCT05475847	Cervical Cancer	Autologous Tumo...	18 Years - 70 Years	Fudan University
Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients	NCT06007586	Gynecological T...	Aprepitant Inje...	20 Years - 75 Years	Sichuan Cancer Hospital and Research Institute
Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients	NCT06007586	Gynecological T...	Aprepitant Inje...	20 Years - 75 Years	Sichuan Cancer Hospital and Research Institute

Spots Global Cancer Trial Database for gynecological tumor