A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)

NCT03468010 | Unknown Phase 3 DMC

• 1 other identifier: B2017-105-01
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 8

Brief Summary

Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.

Conditions

Cervical Cancer; Adjuvant Chemotherapy; Radiation; Lymph Node Metastases

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival (3y-PFS)

  Percentage of patients in a treatment group who are alive without disease get worse for a 3-year period of follow-up after the date of adjuvant chemotherapy completion

  3 years after the date of adjuvant chemotherapy completion

Secondary Outcomes (1)

• Incidence of grade 3/4 adverse event

  Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion

Other Outcomes (1)

• 5-year overall survival (5y-OS)

  5 years after the date of adjuvant chemotherapy completion

Study Arms (2)

The control group (Group A)

ACTIVE COMPARATOR

In Group A, observation is given after chemoradiation

Radiation: chemoradiation

The experiment group (Group B)

EXPERIMENTAL

in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.

Radiation: chemoradiation; Drug: Paclitaxel, Cisplatin

Interventions

chemoradiation RADIATION

radiation with concurrent ciplatin

The control group (Group A); The experiment group (Group B)

Paclitaxel, Cisplatin DRUG

The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks.

The experiment group (Group B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically diagnosed cervical cancer;
• pelvic or para-aortic lymph metastases, at least match one of following
• CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
• pelvic or para-aortic lymph node shows necrosis or extra capsular spread
• PET/CT scan finds positive pelvic or para-aortic node lymph node
• biopsy confirms lymph metastase
• Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
• Karnofsky Performance Scores ≥ 70;

You may not qualify if:

• Patients with distant metastasis before or during radiotherapy
• Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
• Severe neurological, mental or endocrine diseases
• History of other malignancies
• Those who are considered by the researchers unsuitable to participate -

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (8)

Sun Yat-sen University Affiliated Foshan Hospital

Foshan, Guangdong, China

NOT YET RECRUITING

Hospital of of Guangdong Armed Police Corps

Guangzhou, Guangdong, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

The First affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Guangzhou First People's Hospital

Guanzhou, Guangdong, China

NOT YET RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

NOT YET RECRUITING

Hainan General Hospital

Haikou, Hainan, China

NOT YET RECRUITING

Xinjiang Medical University Affiliated Tumor Hospital

Ürümqi, Xinjiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Lymphatic Metastasis

Interventions

Chemoradiotherapy; TP protocol

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Wei-jun Ye, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-jun Ye, M.D

CONTACT

86-13538799871; yewj@sysucc.org.cn

Junyun Li, M.D

CONTACT

86-18824712702; LIJUNY@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: March 16, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 26, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)