Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer

NCT02879214 | Unknown Phase 2 DMC

• 1 other identifier: 201604
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.

Conditions

Squamous Cell Carcinoma of Cervix

Outcome Measures

Primary Outcomes (1)

• To observe the efficacy from radiation therapy dose escalation

  40 participants will be evaluated with treatment-related adverse events as assessed by CTCAE v4.0

  4 year

Secondary Outcomes (2)

• To evaluate the chemoradiation in Stage IIB~ III carcinoma cervix

  4 years

• Disease free survival(DFS)

  4 years

Study Arms (1)

SIDE cervical trial

EXPERIMENTAL

To Maximal downstage locally advanced squamous cell cervical cancer before minimal invasive surgical resection. The SIDE study is to use both RT dose escalation to the biological target defined by PET and Chemo dose escalation composited with two drugs to achieve maximal reduction of tumor burden, providing feasibility of minimal invasive surgical resection.

Radiation: Simultaneous boost along with chemo

Interventions

Simultaneous boost along with chemo RADIATION

Prior studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3), the studies often use single drug. This study treatment plan will use dose intensify in both chemotherapy and radiation. The chemotherapy have two drugs regimens of mitomycin with cisplatin or taxol with cisplatin along of radiation dose escalate, the RT dose escalation to biological GTV defined by PET scan to dose of 57.50 Gy in 25 fx while the elective volumes are held constant at 45 Gy.

SIDE cervical trial

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy confirmed squamous cell carcinoma of cervix, able to receive chemotherapy and concurrent chemoradiotherapy.
• Good performance status. Negative pregnancy test in women of child-bearing potential. Signed study-specific informed consent. Lab results within study specific limits

You may not qualify if:

• Prior radiation to the abdomen or pelvis. A history of Scleroderma or Inflammatory bowel disease. Contraindication to chemotherapy or radiation

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan PPH, Departmentn of Gynecology Oncology

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ming Zeng, MD PhD

  Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Ming Zeng, MD PhD

CONTACT

086-17708131336; miller2002@yahoo.acom

Haixia Pan, MD

CONTACT

086-18981838380

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 25, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

CN (1)