Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer

Squamous Cell Carcinoma of Cervix Clinical Trial

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Official title:

Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer (SIDE, Advanced Squamous Cervical Cancer Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02879214
• Other study ID #: 201604
• Status: Recruiting
• Phase: Phase 2
• First received: August 10, 2016
• Last updated: April 16, 2018
• Start date: December 2015
• Est. completion date: February 2020

Study information

• Verified date: April 2018
• Source: Sichuan Provincial People's Hospital
• Contact: Ming Zeng, MD PhD
• Phone: 086-17708131336
• Email: miller2002[@]yahoo.acom
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Cervix
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Sichuan PPH, Departmentn of Gynecology Oncology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the chemoradiation in Stage IIB~ III carcinoma cervix	40 Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, to see any adverse events within 12 months	4 years
Secondary	Disease free survival(DFS)		4 years