Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer (Side)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02879214
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
ming zeng, MD, Sichuan Provincial People's Hospital

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Cervix Radiation: Simultaneous boost along with chemo Phase 2

Detailed Description:
Concurrent radiation therapy and chemotherapy is the standard of care for locally advanced cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into minimal invasive surgical resection after maximal downstage. This protocol is designed to determine the dose escalation of both chemo and radiation for treating tumor bearing regions within the abdomen and pelvis, using an two drug chemotherapy in first cycle of mitomycin/cisplatin or taxol/cisplatin along with simultaneously integrated boost technique to Biological target area defined by PET scan. This dose escalation is to downstage disease for minimal invasive surgical resection.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer (SIDE, Advanced Squamous Cervical Cancer Trial)
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: SIDE cervical trial
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
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.

Primary Outcome Measures :
  1. To observe the efficacy from radiation therapy dose escalation [ Time Frame: 4 year ]
    40 participants will be evaluated with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures :
  1. To evaluate the chemoradiation in Stage IIB~ III carcinoma cervix [ Time Frame: 4 years ]
    40 Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, to see any adverse events within 12 months

  2. Disease free survival(DFS) [ Time Frame: 4 years ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02879214

Contact: Ming Zeng, MD PhD 086-17708131336 miller2002@yahoo.acom
Contact: Haixia Pan, MD 086-18981838380

China, Sichuan
Sichuan PPH, Departmentn of Gynecology Oncology Recruiting
Chengdu, Sichuan, China, 610072
Contact: Lan Xie, MD    086-87398097      
Contact: Yi Liu, MD    086-87398097      
Sponsors and Collaborators
Sichuan Provincial People's Hospital
Study Chair: Ming Zeng, MD PhD Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences

Responsible Party: ming zeng, MD, Director of Cancer Center, Sichuan Provincial People's Hospital Identifier: NCT02879214     History of Changes
Other Study ID Numbers: 201604
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female