## Protocol Section
### Identification Module
**NCT ID:** NCT06426056

**Brief Title:** Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial.

**Official Title:** Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial.

#### Organization Study ID Info
**ID:** M2024240
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2028-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Jilin Provincial Tumor Hospital

**Class:** OTHER

**Name:** Affiliated Hospital of Hebei University

**Class:** OTHER

**Name:** Hebei Medical University Fourth Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University Third Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer.

### Conditions Module

**Conditions:**

- Cervical Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 64

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).

**Intervention Names:**

- Radiation: radiotherapy

- Drug: Nab paclitaxel

- Drug: Cisplatin

**Label:** Experimental group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week.

**Name:** radiotherapy

**Other Names:**

- RT

**Type:** RADIATION

#### Intervention 2

**Arm Group Labels:**

- Experimental group

**Description:** Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).

**Name:** Nab paclitaxel

**Other Names:**

- paclitaxel for injection (albumin bound)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Experimental group

**Description:** Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).

**Name:** Cisplatin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants

**Measure:** ORR (objective response rate)

**Time Frame:** the 1, 3, 6, 9, 12 months after the end of the treatment

#### Secondary Outcomes

**Description:** adverse events

**Measure:** AE

**Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

**Description:** objective response rate

**Measure:** OS

**Time Frame:** the 1, 2, and 3 years after the end of the treatment

**Description:** progression-free survival

**Measure:** PFS

**Time Frame:** the 1, 2, and 3 years after the end of the treatment

**Description:** duration of response

**Measure:** DOR

**Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

**Description:** disease control rate

**Measure:** DCR

**Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

**Description:** clinical benefit rate

**Measure:** CBR

**Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* (1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system;
* (2) Eastern Cooperative Oncology Group at 2 or less;
* (3) Life expectancy of greater than 3 months;
* (4) Left ventricular ejection fraction at ≥55%;
* (5) Neutrophil count at ≥1500/mm\^3, platelet count at ≥100,000/mm\^3 or hemoglobin at ≥9.0 g/dL;
* (6) Serum creatinine at \<1.5 times the upper limit of the normal reference range;
* (7) Alanine transaminase or aspartate aminotransferase at \>2.5 times the upper limit of the normal reference range;
* (8) Non pregnant or lactating women;
* (9) Women of childbearing age willing to adopt reliable contraceptive measures;
* (10) Sign informed consent form.

Exclusion Criteria:

* (1) Individuals who have previously received chemotherapy with albumin bound paclitaxel;
* (2) Individuals who have previously received abdominal or pelvic radiation therapy;
* (3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy;
* (4) Individuals with central nervous system diseases or brain metastases；
* (5) Other malignant tumors other than cervical cancer have appeared within the past 5 years;
* (6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ;
* (7) The researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc;
* (8) known to be allergic to paclitaxel;
* (9) Received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration;
* (10) Serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia;
* (11) Human immunodeficiency virus (HIV) positive individuals;
* (12) Uncontrolled or active viral hepatitis or infection with human immunodeficiency virus;
* (13) Researchers determine that it is not suitable to participate in this study.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jiangping@bjmu.edu.cn

**Name:** Ping Jiang, doctor

**Phone:** 86010-82266699

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Peking University Third Hospital

**Name:** Ping Jiang, Doctor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002583

- Term: Uterine Cervical Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M6182

- Name: Cisplatin

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

- ID: D000068196

- Term: Albumin-Bound Paclitaxel

### Misc Info Module

- Version Holder: 2024-05-31
