Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer

Phase 2

• Conditions: Squamous Cell Carcinoma of Cervix
• Interventions: Radiation: Simultaneous boost along with chemo

• Registration Number: NCT02879214
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-20
• Study First Posted: 2016-08-25
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18
• Primary Completion: 2019-12
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIDE cervical trial	Simultaneous boost along with chemo	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.

Primary Outcome Measures

Name	Time	Method
To observe the efficacy from radiation therapy dose escalation	4 year	40 participants will be evaluated with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sichuan PPH, Departmentn of Gynecology Oncology; 🇨🇳 Chengdu, Sichuan, China