Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Uterine Cervical Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

All Drugs and Chemicals

Cisplatin

Injection Cisplatin 40mg/m2 weekly for 5 weeks during the entire course of external radiation therapy

CT + RT

Shyamkishore J Shrivastava, MD,DNB(RT)

A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy alone. Concomitant chemoradiation is not a new treatment modality for carcinoma cervix. Studies have shown improvement in survivals with chemoradiation, but majority of the patients was in early stages. Since this treatment modality has not been tested adequately in advanced stages in our setting, the present study is being undertaken. The study arm of chemoradiation has the potential to improve the survivals by 10%, but is associated with additional 5% risk of toxicities, which are treatable. In the study arm, apart form the standard radiotherapy treatment, you will receive weekly chemotherapy injections (Cisplatin) during external radiation therapy. The study arm is associated with additional 5% acute hematological and gastrointestinal toxicities, which are treatable with medications, blood transfusions, modifications in the ongoing treatment etc.

Carcinoma cervix is the commonest malignancy seen in Asian women and constitutes approximately 30% of all cancers (1). It is also the leading cause of cancer mortality in India. Nearly 50% of the patients present with advanced stages (FIGO Stage III/IV). The main stay of treatment has traditionally been radical radiation therapy and over decades the survival rates have achieved a plateau of 30 - 45% at 5 years. In developing countries the socioeconomic problems, illiteracy, late presentation and irregular follow-up have further compromised our survivals. Over the last decade there have been studies on the use of chemo-radiotherapy in carcinoma cervix. Over 19 randomized trials have been published addressing the issue of chemo-radiotherapy. However, heterogeneous data, poor randomization, inadequate number of patients, sub-optimal radiotherapy, non-uniform use of chemotherapeutic drugs, its sequencing and poor documentation have not yet provided the evidence to substantially alter the practice. Hence, meta-analysis of these trials was undertaken to further evaluate the role of chemo-radiotherapy in carcinoma cervix (2,3).

The first meta-analysis published by Cochrane Collaborative Group of 4580 randomized patients (19 randomized trials) suggested that chemo-radiation did show an absolute survival benefit improvement both in progression free and overall survivals by 16% and 12% respectively (p\<0.0001). The survivals were significantly better with Cisplatin based concomitant chemo-radiation (p\<0.0001). Incidentally, the distant metastasis rates were also significantly lower in chemo-radiation (p\<0.0001). However, all these benefits were seen only in early stages. In addition, acute grade 3/4 hematological and gastro-intestinal toxicities were higher with chemo-radiation (additional 8% and 5% respectively). The data was insufficient to report on late toxicity (2).

The second meta-analysis of 9 randomized trials, recently published by the Canadian Group to evaluate only cisplatin based concomitant chemo-radiation confirms the improvement in overall survival (4year survival data) in advanced stages, bulky IB tumors (prior to surgery) and high risk early disease (post-surgery). Although acute grade 3/4 hematological and gastro-intestinal toxicities were higher in chemo-radiation, they were short-lived, with only 2 deaths and the remaining resolved with medical treatment. There was no significant increase in the late toxicity from the data available.

Both the Cochrane and Canadian meta-analysis have to a large extent tried to address the role of concomitant chemo-radiation, but Carcinoma Cervix Stage III accounted for only 30-35% and moreover evaluation with optimal radiation schedules and comparison of late toxicities still remains unanswered. What is more important is that the cisplatin is relatively inexpensive and is available worldwide. This means that cisplatin-based chemo-radiation is affordable in the developing countries where carcinoma cervix still forms the major cancer. However, the role of chemo-radiation in Carcinoma Cervix Stage IIIB in a developing countries including India still remains unexplored. We propose this randomized study to evaluate the role and benefit of chemo-radiation in-patients with cervical cancer.

Concomitant chemo-radiation versus radiation alone

Concomitant Chemoradiation in Advanced Stage Carcinoma Cervix

Concomitant Chemo-radiation in Advanced Stage Carcinoma Cervix: A Phase III Randomized Trial

Individual patient data (IPD) related to patient characteristics, treatment and outcome variables.

Tata Memorial Hospital

Professor and Head, Radiation Oncology

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

weekly cisplatin at 30mg/m2 and paclitaxel at 50mg/m2 are given with concurrent radiotherapy at 2Gy per fraction at 5 fractions per week for 5 weeks followed by either low dose rate (LDR) Intracavitary (I/C) Brachytherapy or supplement Chemoradiotherapy (CRT); if not fit for I/C Brachytherapy

weekly cisplatin @ 40mg/m2 is given along with concurrent radiotherapy at 2Gy per fraction with 5 fractions per week for 5 weeks followed by LDR I/C brachytherapy or supplement CRT; if not fit for I/C Brachytherapy

intravenous paclitaxel infusion at 50mg/m2/week and cisplatin at 30mg/m2/week for 5 weeks. if supplement Chemo Radiotherapy is required then similar dose per week for 2 more weeks.

Paclitaxel, Cisplatin

intravenous infusion of cisplatin 40mg/m2/week for 5 weeks. if I/C Brachytherapy is not feasible then supplement CRT given with similar dose of cisplatin for 2 more cycles.

Pragyat Thakur, MBBS

The purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.

Carcinoma cervix is the 2nd most common malignancy among females and about 86% of this burden occurs in developing countries. India accounts for 27% of world cervical cancer burden; and most of them are of locally advanced stage ie stage IIA to IVA.

Significant development in radiation techniques and addition of cisplatin based chemotherapy to radiation schedule has led to improved survival but still it is far from satisfactory with 20 to 25% patients failing locally while 10 to 20% patients fail at distant sites. Novel techniques are required to improve this dismal rate.

Thus investigators intended to use combination chemotherapy with paclitaxel and cisplatin, considering that paclitaxel is a taxane which has shown good efficacy in other solid tumors such as ovary, lung and breast; it has also shown radiosensitizing effect in cervical cancer cell lines and it has also been shown to be effective in phase III trials with cisplatin in metastatic and recurrent carcinoma cervix.

Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix

to compare clinically, the disease response and local control of combination chemotherapy with weekly cisplatin and paclitaxel with concurrent Radiotherapy Vs single agent cisplatin with concurrent Radiotherapy in locally advanced carcinoma cervix

to monitor number of treatment related adverse events in both the arms

Indira Gandhi Medical College, Shimla

Junior Resident, department of radiotherapy, Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Digestive System Diseases

Symptoms and General Pathology

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Breast Neoplasms

Esophageal Neoplasms

Carcinoma, Hepatocellular

Cholangiocarcinoma

Ascites

Vulvar Neoplasms

Carcinoma, Renal Cell

Hypersensitivity

Carcinoma, Ductal

Carcinoma, Neuroendocrine

Pleural Effusion, Malignant

Pleural Effusion

Mesothelioma

Mesothelioma, Malignant

Anus Neoplasms

Carcinoma, Small Cell

Laryngeal Diseases

Urinary Bladder Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Ovarian Epithelial

Thymoma

Thymus Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Adenocarcinoma

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pleural Diseases

Head and Neck Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Esophageal Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Anus Diseases

Rectal Diseases

Urinary Bladder Diseases

Vulvar Diseases

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Lymphatic Diseases

Esophageal Cancer

Bile Duct Cancer

Diagnosis of any kind of carcinoma with a malignant fluid (pleural effusion or ascites) where drainage is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Diagnosis of any kind of carcinoma where a needle biopsy or tissue resection is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Diagnosis of relapsed multiple myeloma where bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Diagnosis of acute myelogenous leukemia where a blood draw or bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Diagnosis of Stage IV Triple Negative Breast Cancer where a needle biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Diagnosis of any cancer where a blood draw is clinically indicated as part of SOC, a new course of treatment is upcoming, and checkpoint inhibitor therapy being considered for next line of treatment.

Mark Stevens, Ph.D.

Robert Kimmerling, Ph.D.

The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.

Defining the Clinical Potential of Mass Response as a Biomarker for Patient Tumor Sensitivity to Drugs

The best overall response to therapy over 24 months will be captured for correlation with test outcomes.

Travera Inc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concomitant Chemoradiation in Advanced Stage Carcinoma Cervix	NCT00193791	Cancer of Cervi...	CT + RT	18 Years - 65 Years	Tata Memorial Hospital
Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix	NCT01593306	Carcinoma Cervi...	Paclitaxel, Cis... Cisplatin	18 Years - 65 Years	Indira Gandhi Medical College, Shimla
Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix	NCT01593306	Carcinoma Cervi...	Paclitaxel, Cis... Cisplatin	18 Years - 65 Years	Indira Gandhi Medical College, Shimla
Defining the Clinical Potential of Mass Response as a Biomarker for Patient Tumor Sensitivity to Drugs	NCT04985357	Stage III Breas... Stage IV Breast... Stage III Lung ... Stage IV Lung C... AML Multiple Myelom... Carcinoma Carcinoma, Panc... Carcinoma of Lu... Carcinoma, Non-... Carcinoma Breas... Carcinoma Prost... Carcinoma, Hepa... Carcinoma, Rena... Carcinoma, Neur... Carcinoma, Smal... Carcinoma, Ovar... Carcinoma Bladd... Carcinoma of Es... Carcinoma Cervi... Carcinoma, Thym... Carcinoma, Duct... Carcinoma of th... Carcinoma of th... Carcinoma of th... Carcinoma of Un... Carcinoma of th... Carcinoma of th... Carcinoma of th... Carcinoma of th... Carcinoma of th... Carcinoma of th... Carcinoma of th... Carcinoma of th... Malignant Pleur... Malignant Ascit... Mesothelioma Cholangiocarcin...		18 Years -	Travera Inc

Spots Global Cancer Trial Database for carcinoma cervix